Title: Vice President Regulatory Affairs
An exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to have a hands on role in guiding the regulatory strategy for cutting edge therapies in the rare disease space.
Responsibilities:
- Collaborate with cross-functional teams, including clinical, commercial, and medical affairs, to develop and implement global regulatory affairs strategies across a product portfolio.
- Oversee the development and continuous refinement of regulatory policies, procedures, and standard operating procedures (SOPs).
- Partner with commercial, clinical development, and medical affairs teams to design and implement launch strategies, tactics, and lifecycle management plans.
- Conduct regulatory assessments to identify product opportunities, risks, and potential challenges.
- Provide regulatory expertise in the development and approval of promotional materials and marketing campaigns.
- Work closely with legal, commercial, and clinical teams to develop and review product labeling, advertising, and promotional materials to ensure compliance with regulations.
- Lead, mentor, and manage the regulatory affairs team, fostering a culture of compliance and high performance.
- Develop and enhance organizational policies and procedures for regulatory affairs and compliance.
- Anticipate global regulatory changes and proactively adapt strategies to address them.
- Provide strategic guidance on all aspects of regulatory requirements in drug development.
- Interpret communications and decisions from regulatory bodies such as the FDA and international health authorities, developing strategies to resolve issues effectively.
- Draft, review, and submit responses and documentation to regulatory agencies, ensuring compliance with submission requirements.
- Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and follow-up actions.
- Design innovative regulatory strategies for label enhancements and lifecycle product management.
- Advise senior management on the status of global regulatory strategies, tactics, and risk assessments related to regulatory filings.
- Review and approve external communications, advertising, and promotional labeling to ensure compliance with corporate policies and applicable laws.
- Oversee project planning, ensuring priorities are set and key milestones are met in a timely manner.
- Manage collaborations with contract research organizations (CROs) or external partners, ensuring global submissions align with regulatory requirements.
- Maintain up-to-date knowledge of the global regulatory landscape, competitive trends, and regulatory guidelines.
- Establish and direct global benefit-risk strategies for products at all stages of development, including pre-market, post-market, and lifecycle management.
- Perform other duties as necessary, depending on organizational needs.
Qualifications
- Bachelor's degree in a scientific discipline (advanced degree such as Ph.D. or PharmD preferred)
- 15+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industries
- Must have experience in the rare disease space
- Demonstrated ability to design and implement regulatory strategies for innovative products.
- In-depth understanding of FDA regulations, ICH guidelines, and the drug development process.
- Experience preparing regulatory submissions, including INDs and clinical trial documents.
- Prior experience with clinical trials and regulatory documentation is required.
- Experience with inhalation products, biologics, or related areas is preferred.
- Comfortable working in a fast-paced, high-visibility environment with evolving priorities.
- Willingness to travel up to 15%
