215 First Street
Job Category: Clinical: Regulatory
Job Number: 2189
The Director/Sr. Director, CMC Regulatory Affairs will lead the projects and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and marketed products. The incumbent will work closely with subject matter experts and be responsible for assuring the regulatory CMC strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. This position will provide product strategy and direction to commercial and clinical teams internally and agency engagement externally. It requires strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions. Experience working in a matrix environment and excellent people skills are required.
- Lead a product platform team for all regulatory CMC responsibilities
- Prepare and review submission-ready CMC and marketing registration applications, supplements, amendments and variations.
- As a member of the project teams, provide CMC regulatory guidance for global development and registration programs (e.g. INDs, IMPDs, CTAs, BLAs, NDAs and MAAs).
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
- Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for all CMC related issues.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- May manage contract staff and vendors as needed to support Regulatory activities.
REQUIREMENTS / QUALIFCATIONS INCLUDE:
- Ph.D. degree in a biomedical discipline with 5+ years regulatory experience or M.S. with 8+ years regulatory experience, or B.S. with 10 years regulatory experience;
- Experience with preparing INDs, IMPDs, NDA and/or MAA submission(s) is essential.
- Established knowledge of regulatory CMC guidelines and regulations (US and international).
- Prior experience in agency engagement and interaction
- Strong knowledge of eCTD elements and structure and regulatory writing skills.
- Strong knowledge and experience in CMC product development
- Experience with managing a small team
- Regulatory experience supporting both development projects and marketed products.
- Prior hands on experience of FDA CMC regulatory submissions is essential.
- Must thrive working in a fast-paced, innovative environment demonstrating flexibility and a proactive approach.
- Excellent interpersonal and negotiation skills with the ability to develop important relationships with key stakeholders.
- Ability to manage conflict and analyze complex issues to develop relevant and pragmatic plans, programs and recommendations.
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues to a broad audience.
- Possesses strong written and verbal communication and presentation skills.
- Experience working with all levels of management and consulting with key business stakeholders.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Candidates must be authorized to work in the U.S.