Director Or Sr Director Regulatory Affairs - East Coast Remote Flex

Our client is still in stealth mode and has reached a critical point in development - they are seeking a strong regulatory strategist who can join as the first regulatory hire to help with both the tactical, hands-on work involved in setting up a regulatory department, and the development and execution of regulatory strategies. This person will play a critical role role in guiding the company through complex regulatory landscapes. The company has a mainly Oncology focused portfolio and is seeking this experience.

Key Responsibilities:

1. Collaborate cross-functionally with internal teams, including clinical, clinical operations, quality assurance, pharmacovigilance, and non-clinical, to prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
2. Final accountability for regulatory documentation, ensuring adherence to FDA and other health authority specifications and timelines
3. Manage third party vendor partner performance and workload to support regulatory operations and regulatory publishing.
4. Serve as a primary contact and maintain and foster effective relationships with regulatory experts, such as the FDA, EMA, and other regulatory agencies, ensuring open communication.
5. Develop and implement standard operating procedures (SOPs), best practices, and quality control measures to ensure compliance with regulatory standards.
6. Utilize project management tools and methodologies to effectively plan, track, and report on regulatory project status, milestones, and risks.
7. Stay updated on evolving regulatory requirements, guidelines, and industry trends to proactively identify potential risks, opportunities, and impact on the organization.
8. Manage regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.

Qualifications and Skills:

1. Bachelor's degree in life sciences, pharmacy, or a related field with a minimum of 10 years of experience in oncology regulatory affairs within the biopharmaceutical industry. Advanced degree preferred.
2. In-depth knowledge and experience with global regulatory requirements and guidelines (including FDA, EMA, IHC), from preclinical, clinical, and post-marketing stages. Expertise and knowledge of drug laws, regulations, guidelines and lifecycle management.
3. Excellent leadership, communication, and interpersonal skills with the ability to collaborate effectively with internal teams, external partners, and regulatory authorities.
4. Experience in managing regulatory inspections, audits, and interactions with regulatory agencies including direct contact with regulatory agencies.
5. Demonstrated ability to develop, implement, and execute regulatory strategies for complex products or therapies, including regulatory interactions, submissions, filings, and approvals.
6. Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.
7. Detail-oriented with excellent organizational and project management skills, capable of managing multiple projects and priorities simultaneously in a fast-paced environment.
8. Preference for East Coast-based candidates.