Senior Manager, CMC Global Regulatory Affairs

About the role

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule and biological/biotechnological products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include EU/UK/CH and secondarily US/Canada for smooth, timely approvals or continued marketing.

Responsibilities

• Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., MAA/NDA), and post-approval lifecycle activities (extensions/ variations/supplements,) for drug substance, drug products and drug-device combination products.
• Avoidance of regulatory non-compliance by ensuring compliance with global regulations (EMA, FDA, ICH, WHO) and anticipating regulatory changes impacting CMC requirements.
• Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations).
• Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards.
• Lead responses to Health Authority questions and deficiency letters.
• Represent CMC RA in project team meetings and provide expert interpretation of regulatory guidelines and perspective to the cross-functional team.
• Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy).
• Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions.
• Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations.
• Monitor and implement regulatory updates impacting marketed products.
• Represent the company in meetings and negotiations with global Health Authorities for CMC related matters.
• Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late stage product development as well as post approval changes.
• Support departmental initiatives such as preparing/updating departmental job procedures.
• Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.

Requirements

• Education: BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline.
• Experience: 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products.
• Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead.
• Regulatory experience in handling-controlled substance applications will be a plus.

Skills

• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues.
• Knowledge of CMC regulatory requirements during late stage development, initial marketing application and post-approval.
• Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND/IMPD/NDA/MAA/ASMF/CEP, post-approval variations) for EMA, UK, CH and equivalent submissions for US and Canada.
• Comprehensive understanding of the global regulatory environment.
• Strong analytical, problem solving, organizational and negotiation skills.
• Strong ability to work in a matrix environment and across cultural lines.
• Strong leadership, communication, and negotiation skills.
• Ability to manage complex projects and timelines across multiple regions.
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Teams; Sharepoint; Word; Excel; PowerPoint; Outlook).

Qualifications

• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues.
• Knowledge of CMC regulatory requirements during late stage development, initial marketing application and post-approval.
• Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND/IMPD/NDA/MAA/ASMF/CEP, post-approval variations) for EMA, UK, CH and equivalent submissions for US and Canada.
• Comprehensive understanding of the global regulatory environment.
• Strong analytical, problem solving, organizational and negotiation skills.
• Strong ability to work in a matrix environment and across cultural lines.
• Strong leadership, communication, and negotiation skills.
• Ability to manage complex projects and timelines across multiple regions.
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Teams; Sharepoint; Word; Excel; PowerPoint; Outlook).

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement.
• Student loan assistance.
• A generous 401(k) match.
• Flexible time off.
• Paid holidays.
• Paid leave programs.

Pay

$150,034.00 - $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Schedule

Full-time.