Senior Regulatory Affairs Consultant
2 weeks ago
Position Title:
Regulatory Affairs Specialist
Company:
Katalyst HealthCares & Life Sciences
Employment Type:
Contract
Duration:
12 months
Department:
Regulatory Affairs
Qualifications:
Bachelor’s or Master’s degree in a relevant Scientific Discipline
At least 7 years of experience in the pharmaceutical sector
Minimum of 5 years of experience in CMC regulatory affairs (biologics preferred)
Key Responsibilities:
- Develop and implement CMC regulatory strategies for various submissions, including IND/CTA/BLA, NDA, CTD, and MAA filings.
- Oversee the preparation and assessment of CMC submission documents, registration dossiers, and health authority briefing materials.
- Engage with regulatory bodies and represent Regulatory CMC during agency meetings, preparing Subject Matter Experts (SMEs) as necessary.
- Manage CMC activities for specific developmental or commercial products.
- Evaluate regulatory implications of CMC change controls.
- Collaborate with cross-functional teams including GPDO development/commercial and Regulatory Affairs.
- Take a leadership role within CMC development and commercial teams.
- Stay informed about global regulatory frameworks, guidelines, and procedures.
Essential Skills and Knowledge:
- Proven experience with CMC regulatory documentation (NDA, MAA, CTD, BLA, supplements, IND/CTAs).
- Expertise in formulating CMC regulatory strategies with an emphasis on BLA and global biologic marketing applications.
- Comprehensive understanding of FDA, EMEA, and ICH regulations.
- Familiarity with international pre- and post-approval guidelines.
- Strong problem-solving skills with a focus on solutions.
- In-depth knowledge of the biologic drug development lifecycle and post-approval processes.
- Ability to manage complex projects and collaborate within cross-functional teams.
- Previous supervisory or project management experience.
- Knowledge of global CMC regulations pertaining to biological products.
Confidentiality Notice:
All information will be maintained confidentially in accordance with EEO guidelines.
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