Regulatory Affairs Manager – CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate strategies and implement site-specific components for CMC post-market supplements and facility registrations.

• Collaborate with site teams to orchestrate the preparation of regulatory submissions.

• Detect issues and elements that may influence regulatory strategies or operations.

• Deliver impact assessments for deviations, incorporating feedback from CMC Product teams and the CMC Region representative.

• Establish the minimum regulatory filing standards for post-approval initiatives.

• Offer regulatory strategies through the development of MASP and/or GIRS.

• Create post-approval variations.

• Manage applications, including Annual Reports, Distribution Reports, and Annual Stability updates.

• Ensure product compliance through regulatory submissions, actions, and commitments.

• Aid in Change Management efforts.

• Address inquiries from regulatory agencies.

• Facilitate interactions with agencies, including preparation for meetings, conducting meetings, and creating briefing documents.

• Coordinate with development, operations, and commercial teams to synchronize global regulatory strategies, timelines, execution, and plans.

• Contribute to the PDT’s Variation Master Plan.

• Engage actively as a member of cross-functional teams.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of Regulatory Affairs experience OR Bachelor’s degree with 4 years of Regulatory Affairs experience OR Associate’s degree with 8 years of Regulatory Affairs experience OR High school diploma / GED with 10 years of Regulatory Affairs experience.

• A degree in a life sciences field or equivalent relevant experience.

• Experience in Regulatory CMC within the pharmaceutical or biotechnology sector.

• Proficient understanding of ICH guidelines along with current GMP and GCP standards.

• Experience in preparing and assembling regulatory dossiers in alignment with ICH guidelines and the Common Technical Document (CTD) framework.

• Background in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA).

• Sponsorship for this position is not assured.

🏝️ Benefits

• A comprehensive employee benefits package.

• Retirement and Savings Plan featuring generous company contributions.

• Group medical, dental, and vision insurance.

• Life and disability insurance coverage.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Financial plans that offer opportunities to save for retirement or other objectives.

• Career development opportunities.

• Reasonable accommodations available for individuals with disabilities.