For over four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology, and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on research investments. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle to help ensure the continued success of product post-approval.
The Director level Principal Scientist will sit onsite at one of our clients and be the SME for Regulatory Affairs & Product Development. They will lead interactions with the FDA and global health authorities and will lead the submission process to health authorities.
- Develop and implement global regulatory strategies, including the identification of gaps or risks, for products across a range of therapeutic areas
- Prepare regulatory documents including Module 1, meeting requests, meeting information packages, etc. for clients
- Manage multiple types of FDA and global regulatory applications across all phases of product development for clients
- Serve as the Health Authority point of contact (e.g. US Agent, EU Agent, etc.) for clients
- Oversee all aspects of regulatory submissions (e.g., INDs, CTAs, NDAs, BLA, etc.) including, content development and organization, coordination of cross-functional team activities, timeline maintenance, management of project financials, and ensuring of compliance with applicable Health Authority requirements
- Prepare teams for and lead the conduct of milestone development meetings with Health Authorities
- Interact with cross-discipline client teams, including senior executive teams, to contribute strategic advice, insight and business-oriented regulatory opinions
- 10+ years direct FDA and global regulatory affairs experience for drugs
- Advanced technical life science degree (PhD, PharmD, MD, DVM) preferred; minimum Bachelor’s degree in a life science-related discipline
- Regulatory Affairs Certification is preferred, but not required
- Prior regulatory experience with biologic (including Advanced Therapies [e.g., cellular and gene therapies]), combination products and devices is preferred, but not required
- Direct experience communicating and interacting with major Health Authorities, including participating in/leading major interactions such as EOP2, pre-submission and scientific advice meetings
- Extensive regulatory experience specific to drug/biologic development across all product lifecycle stages
- Experience with dossier compilation, submission and approval process in 1 or more major regions
- Solid knowledge of FDA, EMA and other global regulations/regulatory requirements and ICH guidelines
- Demonstrated leadership and program/project management skills, including proven ability to effectively manage cross-functional teams
- Experience working in a matrixed, global and multi-site environment
- Strong written and verbal, analytical, organizational and interpersonal skills
Location: Basking Ridge, NJ
Newark Metro Area, New York City Metro Area
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.