Director Regulatory Affairs CMC

About the role

Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout the lifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on-time submissions with the highest quality to meet global health authority expectations.

Responsibilities

• Serves as regulatory CMC representative on development and marketed product teams.
• Responsible for advising teams on regulatory authority expectations and guidelines and ensure the CMC regulatory strategy is in alignment with the global strategy and with the Target Product Profile.
• Manage interactions with Health Authorities for assigned project(s) to ensure acceptance, rapid review, and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information.
• Maintains an in-depth level of understanding of the company's compounds, their characteristics, manufacturing aspects, and specifications/analytical methods.
• Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submission preparation is expected.
• Coordinate preparation and review technical reports and CMC sections of global submissions to support clinical investigation and marketing applications.
• Ensure compliance with regulatory requirements, strategies, and commitments, which may require partnerships with CROs or others who work on the company's behalf.
• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
• Support CMC QA functions, e.g., deviations, general GMP/regulatory mixed topics.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
• Maintains an advanced level of understanding and awareness of existing and forthcoming legislation to advise project teams accordingly.

Requirements

• Accredited bachelor's degree.
• Minimum of eight (8) years of experience in the Pharmaceutical, Biotech, or Medical Device Industry with direct experience with small molecule/biologic technical functions.
• Minimum of five (5) years of experience in Regulatory CMC with progressive experience in supporting global programs from pre-approval or post-marketing.
• Capability to interact with CMC technical experts regarding process development and analytical issues.
• Demonstrated success in global submission filing, approval, and lifecycle management.
• Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management.

Preferred Qualifications

• Bachelor of Science or Arts Degree; life science-related degree.
• Master or PhD of Science.
• Combination product (drug/device) experience.

Travel

Willingness/Ability to travel up to 10% international travel will be required.

Pay

Salary Pay Range: $220,000 - $250,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan.

Benefits

• Flexible paid time off (PTO).
• Health benefits to include Medical, Dental, and Vision.
• Company match 401k.