The Manager/Senior Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive.
Essential Duties & Responsibilities (Primary):
With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents.
Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters.
Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO's as required.
Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
Strong business acumen and ability to make sound decisions that contribute positively to the business
Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders
Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
Strong negotiating skills and ability to think creatively and develop creative solutions
Proven ability to build trust and respect within the organization.
Ability to prioritize and handle multiple projects simultaneously.
Interacts with external business partners and Regulatory Agencies
Education: Bachelor's degree required, advanced degree preferred
Experience: A minimum of 5 years in the biotechnology or pharmaceutical industry. Preferred candidates will have experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical). Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communications skills are a must as are superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
Business travel to be ~5% as required