Job Description

Senior Manager, Regulatory Affairs CMC

The Senior Manager of Regulatory Affairs CMC will be responsible for managing, evaluating, and completing regulatory projects aligned with company objectives. The Senior Manager will be responsible for primary authorship and supporting CMC regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements.

ESSENTIAL DUTIES

• Serves as the regulatory lead on CMC development teams, providing guidance and oversight.
• Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed.
• Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings.
• Manages administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals.
• Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams.
• Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
• Collaborates and Manage contractors and vendors.

REQUIREMENTS

• 5+ years of experience in CMC Regulatory Affairs.
• Proven success in preparing and submitting CMC sections of INDs, CTAs, NDAs, and MAAs
• Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD.
• Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle.
• Working knowledge of FDA and ICH regulatory guidance and regulations.
• Working knowledge of ex-US regulatory affairs (EMA, MHRA, PMDA) desirable

KNOWLEDGE AND SKILLS REQUIREMENTS

• Ability to multi-task, professional demeanor, strong attention to detail
• High attention to detail and excellent proofreading and editing skills
• Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion
• High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom
• Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
• Must be dependable; someone willing to go the extra-mile to get things done.

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