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.