AI Developer III

AI Developer III 6 months Parkway, NJ Position Summary / Objective: Develop global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. Responsibilities: • Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. • Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities • Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions • Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed • Provide strategic direction (and content input) on US Labeling • Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result. • Foster positive relationships with FDA. • Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development. • Interact routinely and will develop a strong team environment with colleagues throughout GRS Education Requirements: Ph.D., M.D., PharmD., MS or commensurate experience Experience Requirements: Significant experience in regulatory affairs (e.g., 3-5 years) Key Competency Required: • Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA for drug development and approval. • Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology. • Direct experience in developing strategy and leading teams through interactions with FDA. • Extensive experience in initiating and conducting successful interactions within FDA. • Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals Other Qualifications: • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals. • Communicates opinions, facts and thoughts with clarity, transparency, and honesty • Demonstrates ownership of results within (and beyond) area of responsibility. • Sets clear and high expectations and holds self and others accountable for decisions and results achieved. • Looks for opportunities for continuous improvement.

Job Type: Contract

Pay: $70.00 - $75.00 per hour

Expected hours: 40 per week

Experience level:

• 10 years
• 5 years

Schedule:

• Monday to Friday

Education:

• Master's (Preferred)

Experience:

• Regulatory reporting: 2 years (Preferred)

Work Location: In person

Salary : $70 - $75