Title: Associate Director/Director, Regulatory Strategy and Submissions
Location: Waltham, MA
Entasis Therapeutic is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including ETX2514SUL (targeting A. baumannii infections) being initiated for Phase 3 clinical trials, zoliflodacin (targeting Neisseria gonorrhoeae) being initiated for Phase 3 clinical trials, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).
The Associate Director/Director will be a strategic leader for developing a global regulatory strategy for the Entasis portfolio, including leading the team through NDA/MAA submissions for the Phase 3 compound. Serve as corporate liaison with US FDA to develop effective professional relationships as well as a positive company image. Responsible for management of all submission activities in accordance with company and regulatory timelines. Ensure consistent positions are presented in responses to global Health Authority (HA) queries. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines. Provide primary vendor oversight for development and management of submission plans and timelines. Formulates and implements regulatory strategy for labeling development to support successful commercialization of developmental products.
- Regulatory representative to project teams leading global regulatory strategy development and implementation.
- Primary liaison with regulatory authorities
- Manage all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
- Communicate effectively with functional contributors for development of submission documents and track delivery according to agreed timelines.
- Manage and provide vendor oversight for NDA and MAA submission activities including content plan, submission timelines, leading cross-functional team members for development of NDA/MAA documents, IND/CTA amendments, annual reports, etc.
- Provide requested submission documents to partners and CROs.
- Lead the development of briefing documents for formal regulatory meetings.
- Effectively lead key meetings with health authorities to ensure full discussion of issues and opportunities.
- Provide regulatory guidance to cross-functional teams.
- Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Contribute to the development of ex-US regulatory submissions
- Provide vendor oversight for the development of regulatory processes to manage pre-approval compliance activities.
- Assist with regulatory inspection activities.
- Formulate regulatory labeling strategies for implementation of new prescribing information and packaging and backup strategy for label negotiations. Provide expert advice on current labeling requirements and Health Authority-issued guidance.
- Facilitate cross functional labeling teams for successful development, regulatory approval, and implementation of labeling strategies. Provides vendor oversight for development and submission of the final proposed labeling, ensure labeling history is appropriately tracked and information is archived in electronic document management systems.
- Manage and facilitate review for successful development of Company Core Data Sheets.
- Minimum of Bachelor's degree in relevant scientific discipline, higher degree desirable, with 5+ years in the pharmaceutical industry.
- Experience in successfully leading cross-functional teams; ability to broadly represent the regulatory functions on project teams within Entasis. Experience as a member of Global Regulatory Subteam, project working groups, or comparable experience.
- Experience applying project management techniques within teams.
- Direct experience in effectively leading health authority meetings.
- Demonstrated ability to facilitate issue resolution and conflict management.
- Demonstrated ability to organize/prioritize tasks. Strong attention to detail in composing and proofing materials, scheduling and meeting deadlines.
- Demonstrates excellent verbal and written communication skills
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU