Manager Regulatory Affairs

This is an onsite position responsible to prepare and maintain submissions to regulatory agencies and required compliance reports, such as Drug Master Files (DMFs) and Annual Updates and amendments to the DMFs in compliance with ICH Q7, applicable FDA 21 CFR Parts (11, 211, 312, 314, and 610), EudraLex Volume 4, EC No. 726/2004, EC No. 1234/2008, etc.

Responsibilities

• Manage Regulatory Submissions – Ensure timely preparation, submission, and lifecycle management of regulatory filings, including DMFs (Drug Master Files), INDs, NDAs, BLAs, ANDAs, and CTAs.
• Client-Owned Product Support – Work with clients to prepare regulatory filings (e.g., CMC sections) and ensure alignment with their global filing strategies.
• Identify Regulatory Pathways – Assess and recommend the best regulatory strategies for different products and markets, ensuring compliance with FDA, EMA, ICH, and other relevant regulations.
• Maintain Compliance – Monitor regulatory changes and ensure the facility and processes remain compliant with evolving guidelines.
• Cross-Functional Coordination – Work closely with quality, manufacturing, R&D, and supply chain teams to ensure regulatory requirements are met without delays.
• Client & Health Authority Interactions – Act as the primary regulatory liaison for clients and respond to inquiries from regulatory agencies in a timely and effective manner.
• Risk Identification & Mitigation – Proactively identify regulatory risks in submissions and manufacturing changes, working with stakeholders to address them efficiently.
• Ensure Timely Task Completion – Track and drive regulatory timelines, ensuring submissions, renewals, and responses to agency queries are completed as per schedule.
• Regulatory Strategy Development – Define and implement regulatory strategies for new products, process changes, and market expansions.
• Document Control & Data Integrity – Oversee accurate and compliant preparation of regulatory documentation, ensuring alignment with data integrity principles.
• Post-Approval Compliance – Manage post-approval changes, variations, and commitments to regulatory authorities while minimizing delays to client supply.
• Training & Regulatory Awareness – Keep internal teams and clients informed about regulatory expectations and best practices.
• Other duties/projects as assigned.

Job Requirements and Qualifications

This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate’s education, experience, skills, and overall qualifications.

Education

Bachelor’s Degree or above in a Scientific discipline required, Graduate Level Degree in a Scientific discipline preferred.

Experience

• 5 plus years required, 10 plus years preferred.
• RAC-Drugs (Regulatory Affairs Certification) certification
• Experience required with active pharmaceutical ingredient master files (APIMF)
• Experience biologics, process variabilities, developing CMC Chem manufacturing controls used to evaluate process development and the test used
• Experience with stability studies
• Experience with change control assessment for regulatory filings
• In addition, preferred experience with USDA and related agencies import/export regulations and requirements