This client is an established global specialty biopharmaceutical company focused on treating rare diseases. They are in search of a Director, Global Regulatory Lead to develop and direct the global regulatory strategy for the development and marketing of drugs and/or biological products across CNS, Ophthalmology, and Oncology therapeutic areas. This role includes leadership of regulatory strategy for multiple projects and responsibility for support of registrations and life cycle support.
Responsibilities:
- Serves as the US and global regulatory strategy lead for assigned projects. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Proactively identify and assesses regulatory risks associated with product development for assigned projects.
- Leads Global Regulatory Team and represents regulatory affairs function on key internal program teams.
- Coordinates cross-functional group of regulatory professionals as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.
- Leads the development of strategic plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
- Designs and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations.
- Serves as corporate liaison to FDA to develop effective professional relationships as well as positive company image.
- Effectively leads key meetings with US and International HAs to ensure full discussion of issues and opportunities.
- Provides guidance to all appropriate departments to assure compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate
- Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
Qualifications:
- Bachelor’s or Master’s degree required. Advanced degree in science or healthcare or equivalent relevant experience preferred.
- 8+ years of Regulatory Affairs experience. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as the US, EU, Japan and Canada) to ensure ability to provide expert regulatory oversight and guidance for assigned programs.
- Knowledgeable in ICH, FDA, and EMA regulations/guidelines
- Demonstrated knowledge of drug development process
- Must have prior experience working with the FDA and EMA
- Experience working on a successful NDA or BLA a plus but not required
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Excellent interpersonal, communication, analytical, managerial, and organizational skills.
- Ability to effectively present information to senior management, public groups, and other departments.
- Demonstrated ability to motivate, mentor and manage a team in a matrix environment.