美国新泽西药企招聘Regulatory Affairs (Director / SD)

吴红岩医药荐客 2022-01-04

Company Introduction

An emerging company focusing on the development of the best-in-class immunotherapy technology for cancer cure. Teamed up with outstanding immunologists and molecular biologists, has generated a strong pipeline of Chimeric Antigen Receptor (CAR) product candidates to treat a wide variety of liquid and solid tumors.

Location: Piscataway, NJ, USA

Job Details:

Reporting to VP of Regulatory Affairs, the Director/Sr. Director of Regulatory Affairs is responsible for developing, coordinating and executing regulatory strategies and guiding staff at all levels on appropriate regulatory strategies with respect to Nonclinical and Clinical aspects of the programs. The Director/Sr. Director will create strong and effective relationships with other regional and functional regulatory peers and staff on the development of ex-US submission strategies and provide support as needed. This role would represent Regulatory Affairs on needed therapeutic area cross-functional teams and provide oversight across the TA. The individual will interact with FDA and ex-US health authorities as needed and oversee maintenance activities for regulatory filings and ensure timely and high quality submissions.

Responsibilities:

• Responsible to proactively develop innovative, robust global regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development in oncology, Immunology and Infectious diseases.

• Provide oversight with respect to global regulatory strategies for each project within the Therapeutic area(s); ensure timely and high quality submissions; provide guidance and oversight for health authority interactions/meetings.

• Direct the team efforts required for the submission of INDs, CTAs, BLAs, sBLAs and MAAs as well as related supplements/variations and annual reports when necessary. Conduct gap analyses in a timely manner. Oversee the maintenance of INDs and NDAs, and ex-U.S. filings as required.

• Interface with the FDA regarding pre-clinical and clinical development issues and provide support to our ex-US Regulatory counterparts regarding preclinical and clinical support, including the preparation of technical position papers, as needed.

• Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.

• Regulatory representative on due diligence activities for external development candidates

• Coach and mentor junior members in their roles on global project teams and as leader of the global regulatory team.

• Have an understanding of the competitive environment of the various indications in oncology, Immunology and Infectious diseases and support developing products that are differentiated and provide commercial value as well as value for the patient

• Provides regular and timely updates to Sr. regulatory management on the status of all pending applications and planned submissions as necessary.

Qualifications & Skills:

• Minimum M.S. degree in life/health sciences required

• A minimum of 10+ years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Authorization Applications

• Knowledge of global regulatory requirements

• Ability to work independently within project teams, committees, etc. to attain group goals.

• Demonstrate excellent communication skills.

• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.

• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.

• Experience in interfacing with relevant regulatory authorities.

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

往期文章：