About the position:

The Director / Associate Director of Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment and in compliance with local and regional requirements, and company policies. In addition, it will be necessary for the person in this role to have a skill-set suitable to ensuring that submissions meet publishing standards suitable for gateways used by regulatory agencies. This role will ensure effective communication with business partners and representatives of regulatory authorities worldwide, including planning and leading meetings with regulatory authorities. This position will oversee and provide direct input to global regulatory submissions for projects in early & late stage development, including submission of high quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports, annual reports. The person fulfilling this role will work as part of a growing Regulatory Team in a dynamic company. The ability to function independently as well as work collaboratively as part of a cross-functional team, including with external contract research organizations is a must. The opportunity for professional growth is abundant as programs are complex and may involve multiple indications, combination therapies, companion diagnostics, and expedited regulatory pathways.

• Provide regulatory strategic input for global drug development projects, including but not limited, to regulatory requirements, opportunities for expedited development, timing and content of agency interactions, to support successful development programs.
• Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, safety reports, and annual updates/DSURs for assigned projects.
• Interpret and communicate regulatory expectations to stakeholders in order to execute program objectives in compliance with applicable regulations.
• Maintain an awareness and apply a comprehensive understanding of relevant regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
• Ensure that company and project team objectives and timelines are supported by regulatory deliverables.
• Provide de-risking development strategies and evaluate opportunities to accelerate development in a fast-paced environment.
• Represent Regulatory Affairs on global project teams, sub-teams, and external alliances as needed.
• Provide support to clinical study related activities, including interacting with CROs as needed.
• Contribute to the development of policies, procedures and best practices in a rapidly growing company.
• Work as a member of a team, fostering constructive working relationships with internal and external colleagues.

Qualifications/requirements:

• Bachelor’s Degree in clinical, scientific, medical or industry-related discipline is required; Advanced degree (MS, PharmD, PhD) preferred.
• Minimum of five years experience as a regulatory professional in the bio/pharmaceutical industry, including experience interacting directly with regulatory agencies.
• Proven track record of successful regulatory submissions, including major submissions (e.g., IND, CTA, BLA, NDA).
• Document formatting to ensure suitability for regulatory submission gateways.
• Excellent knowledge of FDA and ICH regulations and guidance documents.
• Knowledge of drug development, clinical study design, biostatistics, pharmacokinetics, the regulatory environment.
• Exercises good judgement in elevating and communicating potential or actual issues to line management.

Additional skills/traits:

• Experience with biologics drug development.
• Experience with oncology, especially immuno-oncology drug development.
• Scientific background in immunology, cell biology, cancer therapy.
• Ability to thrive in a collaborative and fast-paced team environment.
• Experience in both early and late stage drug development.
• Recent experience with BLA, NDA, MAA.