Job Description
Role Description
- This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions.
- Responsible for multiple regulatory activities in collaboration with stakeholders (e.g., other RA functions, Pharmaceutical Technology, Quality Assurance, Business Partners).
- Develops global CMC regulatory strategy (e.g., CMC strategy/planning for NMEs).
- Drives global CMC RA related activities and successfully executes regulatory strategies in collaboration with stakeholders.
- Supports business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.
- Qualifications
- BS in Chemistry or equivalent degree.
- 10 years industry experience; pharmaceutical companies, CRO or academic with at least 6 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities.
- Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
- Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
- Advanced interpersonal written and oral communication skills, as well as advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment.
- Ability to manage complex projects by exercising independent decision making and analytical thinking skills.
- Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance.
- Ability to work in cross-functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused.
- Ability to write and speak English fluently.
- Demonstrated track record for successful Health Authority interactions related to CMC submissions.
- Requirements
- M.S. or Ph.D in Chemistry/Biochemistry, PharmD or equivalent degree with 6 years’ experience in CMC regulatory or role with CMC regulatory submission responsibilities (preferred).
- Experience managing direct report is preferred.
- Previous Gene Therapy experience desired.
- Additional experience beyond small molecules, such as biologics, vaccines, cell/gene therapy or medical devices might be a preference.
- Benefits
- Medical, Dental and Vision Insurance.
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down.
- 401(k) match and annual company contribution.
- Company paid 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.
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