Regulatory Affairs Manager CMC
3 weeks ago
Responsibilities:
- Support commercial CMC and GMP activities for contracted manufactured products
- Represent Regulatory Affairs at client meetings, cross-functional meetings, and various project teams.
- Support products to ensure high-quality submissions for INDs, IMPDs, CTAs, and NDAs that align with company strategies and Health Authority requirements.
- Formulate regulatory CMC strategies for product development and commercialization.
- Lead regulatory interactions with third-party clients, serving as the primary liaison.
- Coordinate with contract manufacturing facilities to procure required documentation for third-party licensing activities, ensuring timely provision of documentation for client regulatory compliance.
- Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
- Oversee the maintenance of Drug Master Filings (DMFs), including review, preparation, and updating of CMC information and annual reports.
- Review and approve change controls related to proposed product/process changes and assess their impact on specific regulatory requirements.
- Lead efforts to enhance regulatory standards and initiatives.
- Cultivate productive working relationships with the Regulatory team and other departments.
- Monitor changes in regulations and disseminate relevant information and impact across the organization.
- Define departmental operating standards and ensure adherence to essential procedures.
- Foster relationships and proactively engage with key stakeholders.
- Develop and implement best practices based on current/emerging industry trends and relevant Health Authority guidance and regulations.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field. Advanced degree (e.g., PharmD, PhD) preferred.
- Minimum of 10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Understanding of relevant Health Authority regulations, guidelines, and regulatory trends (FDA, EMA, TGA, Health Canada, ICH, WHO).
- Strong writing skills with the ability to deliver high-quality regulatory documents.
- Excellent judgment in identifying risks and elevating issues to Regulatory Management.
- Related work experience in CMC Regulatory commercial and drug development is required.
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