Senior Manager Regulatory Affairs

Jasper is a biotechnology company focused on enabling cures by targeting mast cells and stem cells. Our mission is to make safer and potentially curative therapy possible for most patients in need. We are bringing together a team of biotech veterans, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision of developing new therapies for diseases of mast and stem cells, safer and more effective conditioning for monogenic diseases and new engineered therapies.

Position Summary:

The Senior Manager, Regulatory Affairs, will be responsible for managing regulatory affairs activities for assigned development programs from preclinical candidate designation through drug approval, including regulatory submissions, such as original INDs & CTAs, amendments/annual reports, and relevant quality documents. Responsibilities include timely planning and coordinating of regulatory submissions, providing support to cross-functional teams on regulatory strategy, working with project teams, assisting with authoring and managing regulatory submissions, archiving and submission tracking. This individual will be responsible for maintaining an in-depth awareness of relevant FDA and EU regulations and policies to optimize regulatory input to assigned projects and teams.

ESSENTIAL FUNCTIONS:

• Maintain up-to-date knowledge of current regulations for applicable territories. •
• Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
• Collaborate on submission content with contributing authors across functional areas to achieve regulatory compliance and ensure data and conclusions are suitable for submission to regulatory agencies.
• Contribute to the development and maintenance of Regulatory Affairs Department working practices and procedures.
• Represent Regulatory for assigned development teams, providing regulatory support in global long-term development planning and implementation of regulatory strategy while ensuring compliance with applicable regulations.
• Assist in the preparation of regulatory-related meetings such as Advisory Boards and Scientific Advice and to prepare draft meeting minutes.
• Contribute to the identification and assessment of relevant news and guidance in order to inform Jasper of potential impact (i.e. Regulatory Intelligence)
• Play a key role in planning, preparation, drafting and review of regulatory documentation, including IND/CTA/BLA/MAA, regulatory interactions, responses to queries from competent authorities, as required for investigational and registration of drugs globally.
• Manage/track regulatory submission documents and timelines, collaborating with Clinical Operations and CROs to ensure timely submissions of all deliverables.
• Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Strong verbal and written communication skills and interpersonal skills.
• Must be able to effectively identify data needs, and successfully present to management.
• Strong collaboration / teamwork skills to efficiently work in a cross-functional environment.
• Is recognized as a knowledgeable resource within the department on focused topics.
• Understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
• Strong organizational skills and ability to work on several projects in alignment with timelines.
• Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject. A relevant master’s degree is preferred.
• 2 years in R&D or related area. Should include 2 years in Regulatory Affairs.
• Work is performed under minimal supervision of a Regulatory Affairs Professional