Aruna Bio is advancing a new class of cell-free biologics, exosomes, for the treatment of central nervous system (CNS) and neurodegenerative disorders and leveraging our novel platform to optimize the delivery of RNAs, antibodies, genes, and small molecules. Through this platform and our partners, we strive to improve outcomes for CNS cancers, neurodegenerative, genetic, and rare diseases.
Aruna Bio currently offers a wide range of full-time employee benefits that include:
· Medical/Dental/Vision insurance options
· Generous Paid Time Off
· Generous Holiday calendar
· Employee retirement plan
· Employee training and professional development opportunities
If you are energetic, highly motivated and want to work in a fast paced, team-focused environment, then Aruna Bio wants to hear from you. The company is currently seeking to fill the following position.
Position Description – Head of Regulatory Affairs
We are seeking a talented, highly motivated and experienced regulatory affairs professional. The Head of Regulatory Affairs will be responsible for developing the global regulatory strategy for development programs in assigned therapeutic areas, assuring that regulatory documents are in compliance with health authority regulations and interacting with U.S. and international health authorities. Reporting to the Head of Research and Development, this position will have regulatory accountability across all development programs and will be responsible for executing and managing the regulatory assignments and interactions for the company.
· Responsible for planning, authoring and executing NDA/MAA’s for global regulatory submissions.
· Developing and leading the regulatory strategy for drug candidates at various stages in the product pipeline, including clinical development through to market approval and ensure concordance with appropriate regulations.
· Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent.
· Ensure effective department procedures, including creating and reviewing SOPs as needed.
· Provide regulatory due diligence and regulatory advice for potential new product opportunities.
· Provide guidance on regulatory mechanisms to optimize product development.
· Work closely with external consultants and partners.
· Develop regulatory strategies aimed at achieving marketing authorization and optimizing product labeling.
· Serve as primary regulatory representative for cross-functional teams.
· Plan, manage and execute regulatory activities, including submission and maintenance of U.S. and international regulatory filings.
· Serve as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for and facilitating sponsor interactions at regulatory meetings, and ensuring appropriate follow-up.
· Participate in the CRO selection process, particularly evaluating regulatory competency and capacity to support international submissions.
· An advanced life science degree (MS, Ph.D.) is preferred with 10 + years of regulatory affairs experience preferred.
· Experience working in the CNS/Neurodegenerative disease therapeutic areas is highly desirable
· Experience working in a small company is highly desirable
· Established relationship with relevant divisions of the FDA
· Late-stage development experience with a track record of successful NDA fillings
· Solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience desirable.
· Knowledge of domestic and international regulations and guidelines regarding drug development, regulatory submissions and corresponding regulatory agency interactions.
· Application experience and proven ability to lead collaborative teams.
· Problem solver with strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills.
· Effective management skills
· Ability to effectively collaborate cross-functionally, across all levels of the organization
· Excellent written and oral communication skills with strict attention to detail
· Proven ability to multi-task and meet multiple high priority deadlines
· Ability to think and work independently with limited supervision while demonstrating personal accountability
Qualified candidates submit cover letter and resume to:
Subject line: Head of Regulatory Affairs