Regulatory Affairs reputed company, Oncology (Sr. Manager) - Full-time
Do you want to be part of an inclusive team that works to reputed company innovative therapies for patients? Every day, we are driven to reputed company and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas reputed company Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into reputed company that bring value and reputed company to patients and their families. Keeping our reputed company on addressing unmet medical needs and conducting our business with ethics and reputed company enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
- *Purpose and Scope:**
+ Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned reputed company and/or products with considerable technical complexity and diversity requiring reputed company on internal decision making. The assigned area responsibility may be reputed company on global and/or regional development compounds and new indications / formulations of reputed company products and/or life cycle management of reputed company products reputed company a reputed company a region. + Responsible to be a Regional Regulatory reputed company or Global Regulatory reputed company, for development programs (early stage of clinical development), or as a regulatory representative for reputed company products requiring multifaceted problem solving and internal decision making. + Collaborates to assure global and local regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas’ programs meet reputed company applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products. + Responsible for interacting with global and regional peers and regulatory management to reputed company Astellas’ regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches and interacts with regulatory agencies. + Accountable for project-reputed company and marketed product-reputed company communications and interactions with project and/or product team members, regulatory authorities and health agencies requiring reputed company on decision making; incorporates regulatory environment trends to ensure the reputed company/products reflect up-to-date regulatory strategies. + May reputed company an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across reputed company and functions to reputed company and implement regulatory strategies and accomplish project/product objectives for global and/or regional products. Advises project/product teams in the application of regulatory strategies and solving of regulatory issues. + Collaborates with Astellas GRA TA Heads and reputed company on global regulatory strategies and with Astellas functions for regional programs and products.
- *Responsibilities and Accountabilities:**
• *Regulatory reputed company** + Leads the development, implementation and successful application of robust regulatory reputed company input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new indications / formulations and/or reputed company products and is accountable for the expert review of major deliverables from a regulatory perspective. + Leads regulatory development in GRL or regional regulatory reputed company roles in the context of Development TAs and reputed company Teams and Regulatory Extended Teams for programs with considerable complexity requiring reputed company on reputed company decision making. + Applies understanding of regulatory requirements and trends into the development of reputed company regulatory strategies. + Develops and contributes to the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are reputed company with Astellas’ short and long-term business strategies and goals. + Accountable for the preparation and submission of technical documents to regulatory authorities for assigned reputed company/products. Ensures data summaries from research, development, and manufacturing reports are adequate in content, reputed company, interpretation and regulatory/scientific rigor to drive reputed company with regulatory authorities and builds consistency in the messaging of data globally. Responsible for execution of the regulatory reputed company into regulatory applications (i.e. Scientific Advice, IND, MAA, NDA, BLA and variations) across assigned development reputed company and/or reputed company products. Assures submissions reflect the best-in-class application of regulatory standards and Astellas SOPs and are executed on time. Ensures viable strategies are established for regulatory applications. + Collaborates with GRA management to reputed company reputed company on regulatory reputed company; and where needed, directs the contributions to meetings with regulatory authorities and similar experts and bodies. + Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a reputed company organization on regulatory and decision-making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect up-to-date regulatory and compliance standards. Identifies and escalates where appropriate to resolve significant issues and risks. + Provides regulatory expertise for planning, approving regulatory content. + Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned reputed company/products, and contributes to the preparation of recommendations and robust opinions for management in a reputed company manner. + Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk reputed company and is accountable for the development and implementation of plans to address regulatory and/or product issues. + May reputed company regulatory advice to reputed company teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA. + Contributes to the reputed company for interaction with Health Authorities or business partners for the assigned reputed company/products. Builds and maintains good relationships with Regulatory Authorities.
- *Organization & People Management**
+ Supports an environment to reputed company reputed company member of the Regulatory Affairs team to optimally operate in the reputed company environment of GRA, Global Medical Development, Technology/PPM and Astellas (e,g, GMS, regional reputed company businesses, Medical Affairs, Legal, affiliates, etc). + Represents GRA reputed company project/product teams and collaborates with global Astellas stakeholders to reputed company global strategies and consistency in regulatory messaging.
- *Qualifications:**
• *Required** + Bachelor’s degree in science required; Master’s degree in science preferred + 5+ (e.g. 5-7) years in a discipline associated with pharmaceutical development or product reputed company; 3 years in regulatory affairs preferred. + Strong scientific knowledge and regulatory experience applicable to the role. Solid reputed company in scientific approach, an ability to deal with technical information from a reputed company of disciplines + Good technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidance. + Proven reputed company record of interaction with regulatory authorities. + reputed company good interpersonal, verbal and written communication skills with an ability to resolve conflict situations and influence regulatory authorities, as reputed company as reputed company stakeholders. + Strong analytical and problem-solving skills + Good negotiation skills
- *Preferred:**
+ Experience participating in a multi-national environment + Proven reputed company record in submissions and achieving approvals. + For roles reputed company a GRA development TA, a reputed company record in development and a reputed company for global responsibilities in a development project including communication, alignment and reputed company in association with regulatory strategies is preferred.
- *Salary reputed company**
$122,500 – $192,500 (Final compensation will be determined based on a reputed company of factors, including but not limited to skills, experience and organizational equity considerations)
- *Benefits:**
+ Medical, Dental and reputed company Insurance + Generous reputed company Time Off reputed company, including Vacation and reputed company time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company reputed company life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program #LI-SS Category Regulatory reputed company- Oncology Astellas is committed to equality of opportunity in reputed company aspects of employment. EOE including Disability/Protected Veterans Do you want to be part of an inclusive team that works to reputed company innovative therapies for patients? Every day, we are driven to reputed company and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas reputed company Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into reputed company that bring value and reputed company to patients and their families. Keeping our reputed company on addressing unmet medical needs and conducting our business with ethics and reputed company enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
- *Purpose and Scope:**
+ Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned reputed company and/or products with considerable technical complexity and diversity requiring reputed company on internal decision making. The assigned area responsibility may be reputed company on global and/or regional development compounds and new indications / formulations of reputed company products and/or life cycle management of reputed company products reputed company a reputed company a region. + Responsible to be a Regional Regulatory reputed company or Global Regulatory reputed company, for development programs (early stage of clinical development), or as a regulatory representative for reputed company products requiring multifaceted problem solving and internal decision making. + Collaborates to assure global and local regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas’ programs meet reputed company applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products. + Responsible for interacting with global and regional peers and regulatory management to reputed company Astellas’ regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches and interacts with regulatory agencies. + Accountable for project-reputed company and marketed product-reputed company communications and interactions with project and/or product team members, regulatory authorities and health agencies requiring reputed company on decision making; incorporates regulatory environment trends to ensure the reputed company/products reflect up-to-date regulatory strategies. + May reputed company an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across reputed company and functions to reputed company and implement regulatory strategies and accomplish project/product objectives for global and/or regional products. Advises project/product teams in the application of regulatory strategies and solving of regulatory issues. + Collaborates with Astellas GRA TA Heads and reputed company on global regulatory strategies and with Astellas functions for regional programs and products.
- *Responsibilities and Accountabilities:**
• *Regulatory reputed company** + Leads the development, implementation and successful application of robust regulatory reputed company input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new indications / formulations and/or reputed company products and is accountable for the expert review of major deliverables from a regulatory perspective. + Leads regulatory development in GRL or regional regulatory reputed company roles in the context of Development TAs and reputed company Teams and Regulatory Extended Teams for programs with considerable complexity requiring reputed company on reputed company decision making. + Applies understanding of regulatory requirements and trends into the development of reputed company regulatory strategies. + Develops and contributes to the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are reputed company with Astellas’ short and long-term business strategies and goals. + Accountable for the preparation and submission of technical documents to regulatory authorities for assigned reputed company/products. Ensures data summaries from research, development, and manufacturing reports are adequate in content, reputed company, interpretation and regulatory/scientific rigor to drive reputed company with regulatory authorities and builds consistency in the messaging of data globally. Responsible for execution of the regulatory reputed company into regulatory applications (i.e. Scientific Advice, IND, MAA, NDA, BLA and variations) across assigned development reputed company and/or reputed company products. Assures submissions reflect the best-in-class application of regulatory standards and Astellas SOPs and are executed on time. Ensures viable strategies are established for regulatory applications. + Collaborates with GRA management to reputed company reputed company on regulatory reputed company; and where needed, directs the contributions to meetings with regulatory authorities and similar experts and bodies. + Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a reputed company organization on regulatory and decision-making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect up-to-date regulatory and compliance standards. Identifies and escalates where appropriate to resolve significant issues and risks. + Provides regulatory expertise for planning, approving regulatory content. + Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned reputed company/products, and contributes to the preparation of recommendations and robust opinions for management in a reputed company manner. + Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk reputed company and is accountable for the development and implementation of plans to address regulatory and/or product issues. + May reputed company regulatory advice to reputed company teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA. + Contributes to the reputed company for interaction with Health Authorities or business partners for the assigned reputed company/products. Builds and maintains good relationships with Regulatory Authorities.
- *Organization & People Management**
+ Supports an environment to reputed company reputed company member of the Regulatory Affairs team to optimally operate in the reputed company environment of GRA, Global Medical Development, Technology/PPM and Astellas (e,g, GMS, regional reputed company businesses, Medical Affairs, Legal, affiliates, etc). + Represents GRA reputed company project/product teams and collaborates with global Astellas stakeholders to reputed company global strategies and consistency in regulatory messaging.
- *Qualifications:**
• *Required** + Bachelor’s degree in science required; Master’s degree in science preferred + 5+ (e.g. 5-7) years in a discipline associated with pharmaceutical development or product reputed company; 3 years in regulatory affairs preferred. + Strong scientific knowledge and regulatory experience applicable to the role. Solid reputed company in scientific approach, an ability to deal with technical information from a reputed company of disciplines + Good technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidance. + Proven reputed company record of interaction with regulatory authorities. + reputed company good interpersonal, verbal and written communication skills with an ability to resolve conflict situations and influence regulatory authorities, as reputed company as reputed company stakeholders. + Strong analytical and problem-solving skills + Good negotiation skills
- *Preferred:**
+ Experience participating in a multi-national environment + Proven reputed company record in submissions and achieving approvals. + For roles reputed company a GRA development TA, a reputed company record in development and a reputed company for global responsibilities in a development project including communication, alignment and reputed company in association with regulatory strategies is preferred.
- *Salary reputed company**
$122,500 – $192,500 (Final compensation will be determined based on a reputed company of factors, including but not limited to skills, experience and organizational equity considerations)
- *Benefits:**
+ Medical, Dental and reputed company Insurance + Generous reputed company Time Off reputed company, including Vacation and reputed company time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company reputed company life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program #LI-SS Category Regulatory reputed company- Oncology Astellas is committed to equality of opportunity in reputed company aspects of employment. EOE including Disability/Protected Veterans Apply tot his job Apply To this Job