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

Calidi Biotherapeutics

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Regulatory Affairs Consultant