The Regulatory Affairs Consultant will provide guidance to Calidi Biotherapeutics to ensure compliance with applicable regulations. This individual will be responsible for developing and implementing regulatory strategies, managing global regulatory submissions, and serving as the primary liaison with regulatory agencies. The consultant will oversee all regulatory submissions, action items, and communications worldwide.
Responsibilities
- Directs regulatory activities across the company’s portfolio, developing and implementing innovative global regulatory strategies, often where no precedent exists
- Stays updated on changing regulations and industry trends to anticipate potential impacts on the company's products and operations
- Develops risk mitigation regulatory strategies for phase appropriate development of biologic product
- Monitors and ensures compliance with all applicable regulatory requirements, including FDA, EMA, ICH, and other relevant guidelines
- Collaborates with cross-functional teams to identify and address compliance gaps
- Leads the preparation and submission of regulatory filings, including investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), and other regulatory submissions
- Manages interactions and negotiations with regulatory agencies to secure timely approvals
- Works closely with Research, Development, Clinical Development, Quality Assurance, Quality Control, Manufacturing, Supply Chain, and other relevant departments to ensure regulatory requirements are integrated into product development plans and processes
- Leads the preparation, review, and submission of regulatory documents, including briefing packages, annual reports, safety updates, and responses to regulatory agency inquiries
- Builds an internal team as necessary over time, responsible for all aspects of regulatory affairs, including regulatory strategy, non-clinical, regulatory CMC, regulatory intelligence, and regulatory operations, utilizing consultants and outsourcing vendors as appropriate
- Establishes and maintains effective professional relationships with FDA and global health authorities; including facilitating, negotiating, and resolving issues as needed
- Seeks for opportunities to get pipeline product FastTrack, orphan drug designation, Breakthrough Therapy, Prime designation
- Partners with and support clinical development, CMC, non-clinical, Quality Assurance, Medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle
- Collaborates and supports Quality Assurance in Regulatory Health Agency inspections and in .responses to findings
- Provides regulatory input to program documents including target product profiles, development plans, and non-clinical and clinical protocols and reports
- Develops standard regulatory procedures from pre-clinical to commercial
- Other duties as assigned
Qualifications
- Advanced Degree Ph.D. or master’s degree with 5+ years of relevant Regulatory Affairs experience in either the pharma or biotech industries (required)
- Exceptional leader with the demonstrated ability to mentor and guide colleagues through all submissions (required)
- Strong oral and written communication skills with the ability to lead and influence at all levels of the organization
- Demonstrated experience in a primary regulatory role s in phases I, II, III with a focus on biologics
- Passionate and thrives in a hands-on, dynamic start- up culture
- Cell and Gene therapy experience is preferred, with a focus on oncology and stem cell products
- Prior experience as a primary regulatory contributor for original IND, NDA, MAA filings in the US and global
- Strong scientific background, with ability to translate highly scientific/technical information to achieve regulatory objectives
- Proven ability to develop and implement a regulatory strategy that evolves and proactively adapts to changes in industry standards
- Deep knowledge of all facets of Regulatory Affairs
- Experience in interfacing and responding to relevant global regulatory authorities
- Expertise in ICH, US and EU regulations and deep understanding of international regulations
- Experience and knowledge in the preparation of Non-clinical, CMC and clinical content for major global regulatory submissions including INDs, BLAs, NDAs, CTAs, license applications, and meeting briefing packages
- Ability to thrive in a fast-paced environment and balance strategic and tactical responsibilities.
- Strong problem-solving skills, with the ability to assess risk and make decisions in ambiguous situations.
- Ability to proactively define, plan, communicate and manage multiple initiatives simultaneously to achieve objectives
