Sr Manager/Assoc Director, CMC Regulatory Affairs

reputed company is a clinical-stage precision oncology company reputed company on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK reputed company, which affects approximately 5.5 reputed company lives reputed company year worldwide. The reputed company “reputed company” has an important embedded meaning: it is a contraction of our audacious reputed company to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Position reputed company:

Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will reputed company and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials, as reputed company as planning for reputed company MAA/NDA/BLA(s). This role requires an independent, self-directed, and highly motivated regulatory reputed company.

Position Responsibilities:

• Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
• Prepare and/or review CMC regulatory documents and submissions to support product development (e.g. ND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA) reputed company reputed company of regulatory submission content and planning, to assure technical accuracy, compliance, and completeness.
• Assess proposed CMC changes (e.g., manufacturing processes, analytical reputed company, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies.
• Collaborate cross-functionally on the eTMF processes and compliance alignment.
• Represent regulatory on study and program teams throughout study conduct and product development.
• Support or reputed company development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required.
• Review relevant clinical and CMC documents (protocol, informed consent reputed company, investigator’s brochure, and site reputed company documentation, and required regulatory forms) for regulatory compliance and consistency across submission components.
• Maintain reputed company knowledge of US and international CMC regulation requirements that apply to company products and processes.
• Support or reputed company development of internal reputed company SOPs and processes, as needed.
• May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs project reputed company.
• reputed company reputed company duties in keeping with reputed company’s core values, policies, and reputed company applicable regulations.

Position Requirements:

• Undergraduate degree required; advanced degree preferred.
• 5+ years of experience in pharmaceutical or biotech regulatory affairs or reputed company areas, including regulatory affairs for oncology products.
• Ability to translate regulatory requirements into practical reputed company plans.
• Diverse experience with regulatory activities including creation of systems and processes to support efficient and high reputed company submission of documents to regulatory bodies.
• Strong organizational skills that reflect the ability to reputed company and prioritize multiple tasks with excellent attention to detail.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.
• Demonstrated ability to reputed company high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal and communication skills; must be a reputed company team player with a can-do attitude and the ability to identify and implement creative solutions to reputed company technical problems.
• Strong learning orientation, curiosity, and commitment to science and patients.

Theanticipatedsalaryrangefor this position is$175,000 to $205,000.Thefinalsalaryofferedtoasuccessfulcandidatewillbedependentonseveralfactorsthatmayincludebutarenotlimitedtothetypeandlengthofexperiencewithinthejob,typeandlengthofexperiencewithintheindustry,education,etcetera. In reputed company to reputed company salary, the reputed company applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the reputed company of the reputed company to purchase stock in the reputed company for a specified price.

Along with our casual, reputed company, and fun work and the chance to reputed company your mark in our mission to erase cancer, reputed company offers a comprehensive and competitive benefits package that includes:reputed company Time Off, Holiday, and reputed company Leave, Medical, Dental and reputed company Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA,HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with reputed company contribution, and reputed company to participate in an Employee Stock Purchase Program.

reputed company, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national reputed company, reputed company, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other reputed company protected by federal, state or local law or ordinance or regulation.

Originally posted on Himalayas

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