Vacancy caducado!
Basic Qualifications
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
Responsibilities
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
Location : Basking Ridge, NJCardinal 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.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.