Head of Regulatory CMC
Stirling Q&R
Boston, massachusetts
Job Details
Full-time
Full Job Description
Position Title:
Head of Regulatory CMC
Company Overview:
Stirling Q&R is seeking a dynamic and experienced Head of Regulatory CMC (Chemistry, Manufacturing, and Controls) to lead our regulatory efforts in ensuring compliance with CMC requirements for our pharmaceutical and biotech products. This strategic role will play a key part in bridging the gap between manufacturing and regulatory affairs.
Key Responsibilities:
- Lead the development and execution of regulatory CMC strategies that align with product development timelines and company objectives.
- Oversee the preparation and submission of CMC documentation to regulatory agencies, ensuring compliance with global regulations.
- Collaborate closely with R&D, Quality Assurance, and Manufacturing teams to ensure that all aspects of CMC are addressed in regulatory submissions.
- Act as the primary point of contact for regulatory authorities during CMC-related inquiries and inspections.
- Monitor and interpret changes in CMC regulations and guidelines, advising internal teams on implications and necessary actions.
- Provide leadership and mentorship to a team of regulatory professionals specializing in CMC.
- Support product lifecycle management and ensure timely updates of regulatory filings as necessary.
Requirements
Qualifications:
- Advanced degree (PhD or MS) in life sciences, chemistry, or a related field.
- Minimum of 10 years of regulatory CMC experience in the pharmaceutical or biotech industry, with at least 5 years in a leadership position.
- Comprehensive understanding of CMC regulations and guidelines, particularly FDA and EMA requirements.
- Proven ability to manage complex regulatory submissions and navigate regulatory processes.
- Strong leadership skills with experience in managing teams and building collaborative relationships across departments.
- Exceptional communication skills, both written and verbal, with the ability to influence stakeholders at all levels.
- Strong analytical skills and a detail-oriented approach to regulatory compliance.