Associate Manager CMC Regulatory Compliance

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

About the role

As the Associate Manager Regulatory CMC (RCMC), you are responsible for supporting all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document, as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide. You will serve as the liaison with the Global Healthcare Operations and R&D functions, being the contact person for all Regulatory CMC topics.

Location: Hybrid (3x/week) in Billerica, MA office.

Responsibilities

• Ensures global product oversight for the Regulatory CMC part of their product(s) / project(s).
• Supports the development and definition of the Global Regulatory CMC strategy for development programs (pre-clinical to commercial application).
• Leads and drives global regulatory CMC strategy for the assigned projects/products in target regions/countries, encompassing responsibility for Regulatory CMC topics, risk assessment & mitigation, and strategic support to interdisciplinary internal teams.
• Supports the preparation of Health Authority (HA) meetings and interactions on CMC topics.
• Responsible and accountable for driving all regulatory CMC activities for assigned projects/products, including CMC Dossier types such as IMPD/IND, HA Meeting Packages, variations, amendments, Module 1 CMC regulatory binding documents, Annual reports, CMC information in the Investigators Brochure, and HA questions up to approval.
• Provides Global Regulatory CMC advice & expertise in cross-functional project teams.
• Acts as liaison between Global Health Operations and R&D functions as single point of contact for all CMC topics.
• Supports the development and provision of country-specific regulatory CMC requirements for CMC dossier strategies and plans.
• Reviews draft and newly released laws and guidance on behalf of the Company.
• Leads and participates in internal as well as cross-functional, international initiatives.
• Supports development and execution of initiatives, plans regulatory CMC activities, and develops submission roll-out plans in close collaboration with key stakeholders.

Requirements

• Bachelor’s Degree in a Life Science discipline.
• 1+ years of pharmaceutical industry or academia experience and regulatory or CMC knowledge.

Qualifications

• Master’s Degree or PhD (preferred).
• Strong written and verbal skills.
• Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers.
• Experience in preparation of regulatory CMC documentation.
• Experience with life-cycle management activities in EU, USA, and International markets.
• Practical experience in one of the following areas: manufacturing process development, transfers, validation, or analytical development and control strategies.

Pay

Pay range for this position: $77,800 - $116,700. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

• Health insurance.
• Paid time off (PTO).
• Retirement contributions.
• Other perquisites.

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace.