Sr. Regulatory CMC Manager
About The Position
Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The Sr. Regulatory CMC Manager will be responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects, aiming for successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner. This role involves developing CMC regulatory plans, providing expertise on global regulatory CMC requirements, offering expert advice to product development teams, leading interactions and negotiations with regulatory agencies, and potentially leading the preparation of regulatory submissions. The position also includes creating, reviewing, and editing reports and submissions, engaging with stakeholder groups, and potentially acting as a regulatory CMC liaison with partner companies and contract manufacturers.
Requirements
- BS/BA degree in Life/Health Sciences or related field AND 8+ years of Regulatory Affairs experience in a pharmaceutical company with focus on CMC activities. Experience managing external contract services, and direct interaction with FDA.
- OR Master’s degree in Life/Health Sciences or related field AND 6+ years of similar experience.
- OR PhD AND 4+ years of similar experience.
- Demonstrates broad expertise or unique knowledge.
- Considered an expert within the company and may have external presence in area of expertise.
- Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team.
- Ability to work as part of and lead multiple teams.
- Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.
- Excellent computer skills.
- Excellent communications, problem-solving, analytical thinking skills.
- Sees broader picture and longer-term impact on division/company.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
- Excellent project management, strong project leadership skills.
- Anticipates business and industry issues; recommends relevant process / technical / service improvements.
- Strong knowledge of FDA regulations, including current Good Manufacturing Practices.
- Proven experience with electronic filing (eCTD), electronic document management systems and with document review and approval processes.
- Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals.
Responsibilities
- Contributing to the regulatory CMC strategy and execution for assigned commercial and development projects.
- Responsibility for significant contributions to IND/CTA preparation, maintenance, and update activities.
- Interaction with and preparation for key milestone meetings with regulatory agencies with a focus on CMC aspects.
- Developing CMC regulatory plans to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities.
- Providing expertise on global regulatory CMC requirements to management and project teams.
- Providing expert advice to product development teams within CMC areas on all regulatory issues for the development, planning, compilation, and submission of IND/CTA/MAA/NDA/BLA.
- Leading interactions and negotiations with regulatory agencies during all stages of development and registration.
- May lead preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA).
- Creating, reviewing, and editing reports and regulatory submissions.
- Actively engaging with stakeholder groups to help shape science-based regulatory decision making.
- May act as regulatory CMC liaison with partner companies and contract manufacturers.
- Other duties as assigned.
Benefits
- Annual bonus with a target of 30% of the earned base salary.
- Eligibility to participate in our equity based long term incentive program.
- Retirement savings plan (with company match).
- Paid vacation, holiday and personal days.
- Paid caregiver/parental and medical leave.
- Health benefits to include medical, prescription drug, dental and vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
