Associate Manager CMC Regulatory Compliance

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 77,800 - 116,700; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other perquisites

Job summary

MilliporeSigma is seeking an Associate Manager Regulatory CMC (RCMC) to support global regulatory CMC activities, authoring, and dossier ownership for assigned submissions worldwide. The role partners with Global Health Operations and R&D, acting as main contact on CMC topics.

The position is hybrid with 3 days on-site in the Billerica, MA office and requires regulatory knowledge and strong communication skills to drive CMC strategies and interactions with Health Authorities.

Qualifications

• Bachelor’s Degree in a Life Science discipline is required.
• 1+ years of pharma industry or academia experience with regulatory or CMC knowledge.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Global Product Oversight for the Regulatory CMC portion of products/projects.
• Develop and drive Global Regulatory CMC strategy; support HA meetings and interactions.
• Manage CMC regulatory activities and dossier generation (IMPD/IND, HAs, variations, modules, reports).
• Provide Global Regulatory CMC advice in cross-functional teams and coordinate with Global Health Operations and R&D.

Skills

Regulatory CMC knowledge

Regulatory strategy development

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's Degree in Life Science

Master's Degree or PhD

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma. 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. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your 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, and 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

Key Accountabilities

Global Product Oversight

• Ensures global product oversight for the Regulatory CMC part of their product(s) / project(s)

Regulatory CMC Strategy And Health Authority Interactions

• 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. This encompasses responsibility for the Regulatory CMC topics, risk assessment & mitigation, regulatory CMC strategic support and advice to interdisciplinary internal teams
• Supports the preparation of HA meetings and Health Authority interactions on CMC topics

Management of CMC Regulatory Activities; CMC Dossier generation

• Responsible and accountable for driving all regulatory CMC activities for assigned projects/products.
• Responsible for CMC Dossier types such as IMPD/IND, Health Authority Meeting Packages (incl. meeting request), variations, amendments, Module 1 CMC regulatory binding documents, Annual reports, CMC information in the Investigators Brochure, and Health Authority questions up to approval.
• Provides the 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.

Regulatory Intelligence And Knowledge Management

• Reviews draft and newly released laws and guidance on behalf of the Company. Leading and participation in internal as well as cross-functional, international initiatives.

Global Regulatory Affairs CMC Coordination

• Supports development and execute initiatives
• Plans regulatory CMC activities and develops submission roll-out plans, in close collaboration with key stakeholders

Who You Are

Minimum Qualifications

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

Preferred Qualifications

• Master’s Degree or PhD
• 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
• Practical experience in one of the following areas: manufacturing process development, transfers, validation or analytical development and control strategies

Pay Range for this position - $77,800 - $116,700.

The offer range represents the anticipated low and high end of the base pay compensation for this position. 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 offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer: 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. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!