Sr. Regulatory CMC Manager

Neurocrine Biosciences • San Diego, CA

5d • Onsite

About The Position

Responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner.

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 noted above
• OR PhD AND 4+ years of similar experience noted above
• 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

• Responsible for contributing to the regulatory CMC strategy and execution for assigned commercial and development projects, including responsibility for significant contributions to IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects
• Develops CMC regulatory plans to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities
• Provides expertise on global regulatory CMC requirements to management and project teams
• Provides expert advice to product development team within CMC areas on all regulatory issues for the development, planning, compilation and submission of IND/CTA/MAA/NDA/BLA
• Leads interactions and negotiations with regulatory agencies during all stages of development and registration
• May lead preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA).
• Creates, reviews and edits reports and regulatory submissions
• Actively engages 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior