Director, RA CMC

About the role

The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. They prepare CMC regulatory strategies that enable first pass approvals, develop and manage content strategy for regulatory submissions, and build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations.

Responsibilities

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new IND/CTA applications and amendments, new marketing authorization submissions, renewals, annual reports, supplements and variations, and/or leads a global RA CMC team who develops strategies for development and marketed products
• Advises internal personnel on regulatory strategies. Provides strategic regulatory advice to peers and management in RA, R&D, and Operations. Seeks internal and external expert advice and technical support when necessary.
• Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies. Devises regulatory strategies for complicated scenarios (e.g., complex dosage form or multiple operational changes, aggressive timelines).
• Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages. Serves as the point of contact for the regulatory agency meetings and leads CMC discussion for projects with health authorities. Drives strategic change planning with Manufacturing Operations using a risk-based approach centered on assessment of potential impact to quality, safety or efficacy.
• Manages products and change control in compliance with an understanding of regulations, guidances and company policies and procedures. Analyzes and approves manufacturing change records.
• Represents RA CMC on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in external regulatory environment. Analyzes legislation, regulation and guidance and provides analysis to the organization. Leads creation of white papers and policies to illustrate current regulatory thinking.
• Designs initiatives to drive business efficiencies across the organization (within or outside of the regulatory groups). Ensures enterprise culture initiatives are implemented across RA CMC.
• Trains, develops and mentors individuals; may include formal supervisory responsibilities of product leads. Evaluates performance of and assists in career development planning for assigned staff.

Requirements

• Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Preferred Education: Relevant advanced degree preferred. Certification a plus
• Required Experience: 10 years biopharmaceutical experience with 3-plus years demonstrated enterprise leadership. 5-plus years in RA or relevant exposure to RA activities
• Preferred Experience: 10-plus years biopharmaceutical RA, R&D, or Operations experience, including 7-plus years in regulatory affairs
• Experience developing and implementing successful global regulatory strategies
• Interfacing ability with government regulatory agencies
• Success leading in a complex and matrix environment.
• Strong understanding of the business/enterprise
• Strong oral and written communication skills.

Qualifications

• Strong understanding of regulatory processes and guidelines
• Proven track record of successful regulatory submissions and approvals
• Excellent interpersonal and negotiation skills
• Ability to manage multiple projects simultaneously
• Strong analytical and problem-solving skills

Skills

• Regulatory Affairs
• Chemistry, Manufacturing and Controls (CMC)
• Strategic Planning
• Project Management
• Leadership
• Communication

Benefits

• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
• Long-term incentive programs

Pay

$160,500 - $305,000 USD

Schedule

Hybrid