Associate Manager CMC Regulatory Compliance

Biopharma Careers; Billerica (MA); Hybrid; USD 78,000 - 117,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma in the United States is seeking an Associate Manager Regulatory CMC to support all CMC regulatory activities, own the CMC dossier strategy, and lead dossier content decisions for worldwide submissions. Hybrid work in Billerica, MA, with responsibilities spanning strategy, HA interactions, and dossier generation.

Minimum qualifications include a life sciences bachelor’s and 1+ year regulatory experience; advanced degrees preferred.

Qualifications

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

Responsibilities

• Global Regulatory CMC coordination and plan execution.
• Support development of Global Regulatory CMC strategy for development programs.
• Prepare regulatory CMC documentation and submissions (IMPD/IND, HA meetings, variations, amendments).
• Provide regulatory CMC advice in cross-functional teams and liaise with Global Health Operations and R&D.

Skills

Regulatory knowledge

Regulatory strategy development

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.

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.

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

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.

For more information click here.

RSREMD

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!