Associate Principal Scientist, Regulatory Affairs, Site CMC

Merck KGaA Darmstadt Germany - Wilson, NC

Full-time - Mid Level

Onsite - Wilson, NC

Chemical Manufacturing

About the position

The candidate will be part of the Global Regulatory & CMC organization, supporting the Americas Site CMC team at the Wilson site. This role is crucial for ensuring product compliance with approved Marketing Authorizations and facilitating change control and regulatory submission activities. The position involves collaboration with various teams to ensure regulatory information is accurately maintained and aligned with site practices, ultimately supporting ongoing compliance and product release.

Responsibilities

• Identify and assess change controls for potential regulatory impact and requirements.
• Collaborate with CMC functional teams to progress regulatory post-approval changes efficiently through to market approval and implementation.
• Ensure information included in CMC filings aligns with site information and practices for ongoing compliance.
• Maintain, update, and interpret regulatory information using business processes, systems, and tools.
• Provide CMC guidance to site Quality, Technical, and Supply Chain functions for product release according to Global Marketing Authorizations.
• Engage in CMC product and site-based project teams for new product and market launches.
• Coordinate submission component authoring for post-approval CMC changes and responses to Health Authority questions.
• Participate in CMC product teams to provide site strategy and data requirements for submissions.
• Support Health Authority notifiable events, investigations, and deviations with regulatory impact.
• Serve as CMC point contact for site GMP Health Authority inspections.

Requirements

• Bachelor's degree in a science, engineering, or related field (advanced degree preferred).
• At least five (5) years of relevant experience in the Bio/Pharmaceutical industry.
• Good understanding of and experience with internal commercial manufacturing organizations and/or contract manufacturing organizations.
• Ability to manage competing demands of site and corporate stakeholders effectively.
• Proven ability to communicate effectively in both written and verbal formats.
• Ability to influence and work independently and collaboratively in a team structure, including virtual teams.
• Demonstrated effective problem-solving skills and excellent interpersonal skills.
• Detail-oriented with the ability to prioritize multiple tasks and work well under pressure.

Nice-to-haves

• Knowledge of global regulatory requirements and regulatory strategies.
• Knowledge of commercial packaging activities including change control and product lifecycle management.
• At least 3 years of CMC-related experience.
• Candidates with a technical and scientific background and prior engagement with Regulatory CMC projects will be considered.

Benefits

• Hybrid work model with three days on-site per week and one remote working day.
• Commitment to inclusion and diversity in the workplace.