Senior Director, Regulatory Advertising and Promotion - Boston
Boston, Massachusetts, United States
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created three years ago, it is in an exciting start-up phase where a Regulatory Affairs professional can have a real impact on the work and foundations that are being created. This role will report directly to the Chief Regulatory Officer based in Europe and will be a key asset in the development and commercialization of exciting ex-vivo Gene Therapy Products. This opportunity is unique due to the size of the team and the ground-breaking science.
The Sr/Director, Regulatory Advertising and Promotion will be responsible for providing strategic guidance and leadership on the development and implementation of a compliant advertising and promotion program for pre-launch and commercial activities related to the rare disease portfolio. The position will require working with limited supervision to review and provide strategic advice on advertising and promotional materials in accordance with the US FDA requirements and applicable other regions, company policies and business goals and objectives.
- Represent the regulatory department in cross-functional meetings and communicate global regulatory advertising and promotional strategy and risk analysis
- Serves as the primary regulatory reviewer on the Orchard Medical, Legal and Regulatory Review Committee for assigned gene therapy products for global core materials and US materials including promotional, corporate and other non-promotional materials.
- Serve as the chair for the Global/US MLR committee
- Serve as primary point of contact to the FDA’s APLB, ensuring materials are submitted in a timely fashion, responding to agency inquiries and managing company requests for all assigned Orchard products
- Collaborate with colleagues or suppliers serving as regulatory reviewers in EU/ROW MLR committees to align practices as far as possible and consolidate experience
- Ensure effective communication and constructive relationships with internal/external stakeholders
- Contribute to the development and implementation of regulatory strategy for promotional labeling
- Review the content of labeling of all assigned Orchard products; work with US Regulatory counterparts to ensure regulatory strategy will result in commercially viable US labeling and that planned pre- and post-approval studies will support desired promotional claims
- Identify and provide guidance on development and improvement of policies, processes, and standards for promotional materials and related activities, including the submission of materials to FDA
- Lead the regulatory intelligence activities for advertising and promotion by monitoring regulatory guidelines and trends
- Contribute to the development and implementation of regulatory advertising and promotion training for cross-functional partners
- Collaborate with colleagues in Medical Affairs, Legal, and Commercial and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s)
- Ensure that changes to the U.S. Prescribing Information are incorporated into external communications in a timely manner
- BA/BS degree, advanced degree preferred (MS, PhD, PharmD)
- At least 8 years’ experience in industry‑related Regulatory advertising and promotion review with in depth knowledge of US FDA regulations for advertising and promotion
- Experience with launching new products with experience in biologics and/or rare disease preferable
- Direct experience working on accelerated approved products
- Experience with ex-US promotional activities a plus
- Ability to work with minimal supervision and with remote teams
- Excellent communication skills including communication with senior management
- Ability to resolve conflicts with good negotiation skills
- Ability to communicate in a timely and consistent manner
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs such as a stock option plan and ESPP. Orchard Therapeutics offers a comprehensive benefits program, including: private medical cover, dental and vision care, group pension, life insurance and long-term illness cover. Orchard Therapeutics is an equal opportunity employer.