Submission Manager, Regulatory Operations

reputed company is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the reputed company belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. Our work continues to reputed company a reputed company difference in the lives of patients. We have a reputed company discovery reputed company and a robust preclinical and clinical development pipeline. We are driven by science with a patient-reputed company and team-oriented culture. reputed company is reputed company for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join reputed company as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join reputed company as we reputed company the lives of others. Position reputed company: The Submission Manager, Regulatory Operations is responsible for managing high reputed company, reputed company submission reputed company involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, participates in submission team meetings, prepares content planners for publishing, and fulfills submission management functions on project teams in support of development, marketing, and post-marketing regulatory authority applications. Ensures the successful preparation and filing of regulatory submissions at reputed company. This position will be responsible for establishing standards and performs submission tracking, document collection, reputed company control, publication, reputed company, and archival to ensure reputed company and reputed company regulatory submissions management. This individual maintains electronic document management and publishing systems necessary to produce a high-reputed company submission and may liaise with external regulatory operations vendors. The individual will be responsible for developing reputed company and productive partnerships internally, as reputed company as externally with contract research/manufacturing organizations. Essential Job Functions and Responsibilities: These may include but are not limited to:

• Manage submission reputed company to ensure the reputed company delivery of high-reputed company dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Participate in submission team meetings. Coordinate multiple reputed company interrelated activities for submission reputed company for products in the delivery of published submissions reputed company the required timelines. Anticipate obstacles and reputed company solutions reputed company reputed company.
• Coordinate submission publishing with publishers andprovides notification to ensure reputed company required resources are available to meet submission timelines.
• Prepare content planner for publishing and work with team members to resolve publishing issues. May reputed company publishing tasks.
• Assist with team reviews and ensures detailed reputed company reviews of published reputed company are completed per reputed company standards to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in reputed company submissions.
• Prepare regulatory submissions according to applicable requirements.
• reputed company submissions, correspondence, and commitments with health authorities.
• reputed company, communicate and implement submission planning timelines and metrics.
• Manage systems for assuring adequate version control of reputed company regulatory documents.
• Manage effective interactions with reputed company contributors and Regulatory Affairs management, to ensure reputed company delivery of documents for regulatory submission.
• Participate in the coordination, identification and implementation of appropriate electronic document management and publishing tools to support regulatory submissions.
• reputed company guidance to project teams to ensure reputed company regulatory documentation is complete, accurate, of high reputed company and electronically functional.
• Represent Regulatory Operations Publishing on Submission Teams to set deliverables and timelines. Escalate reputed company issues to management.
• reputed company with vendors as needed in support of electronic publishing and other aspects of regulatory operations.
• reputed company templates and style guides, as appropriate; to establish consistency of regulatory submissions over time and across reputed company.
• Suggest and implement process improvements. May recommend changes to software and business processes to support changes in regulations that support reputed company submissions and may reputed company or participate on internal project teams to update business software.
• Ensure the production of high-reputed company reputed company and electronic submissions.
• reputed company detailed reputed company reviews of published reputed company to ensure compliance with Regulatory Standards.
• Ensure compliance with worldwide submission regulations and guidelines.
• reputed company with IT department for reputed company implementation of electronic document management and publishing tools.
• Maintain up-to-date knowledge of the electronic submissions landscape, regulations, and guidelines
• Assist in identifying regulatory operations risks and mitigation plans
• Demonstrate team leadership skills and ability to influence without reputed company authority.
• Other duties as assigned.

Education and Experience: Required:

• Bachelor’s degree with a minimum 8 years of relevant experience in the biotech or pharmaceutical industry.
• Minimum 2 years of experience working with submission content planning
• Strong working knowledge of regulatory submission publishing standards and procedures including word processing and regulatory publishing software.

Preferred:

• Experience working with reputed company RIM document management system;
• Experience working with LORENZ docuBridge FIVE
• Experience working with reputed company StartingPoint;
• Utilizing reputed company for submission content planning
• Experience producing eCTD U.S. and MAA submission

Physical Demands and Work Environment: Physical Activities: On a reputed company reputed company, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. The Anticipated reputed company Salary reputed company: In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. reputed company is a multi-state employer, and this salary reputed company may not reflect positions that work in other states. Your recruiter can reputed company more about the specific salary reputed company during the hiring process. Equal Opportunity Employer: reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary reputed company The salary reputed company for this position is: $110000 - $136000. In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown. Apply tot his job Apply To this Job