AI Developer

Hi,

Hope you are doing well!

Please find the below job description and let me know if you are interested, thank you.

Job Title: AI Developer
Work Location: JFK Parkway, NJ (Remote)
Duration: Long term

Job Description:

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.

Thanks and Regards

George,

Sr Recruiter,

iTek People Inc,

13706 Research Blvd, Suite: 307

Austin, TX-78750

Direct:

Work: *113,

Email: George