Senior Vice President, Regulatory Affairs
Cranbury, NJ, US
SUMMARY:
Our client is looking to hire for a Senior Vice President of Regulatory Affairs to oversee their regulatory strategy practices and submissions of approvals to the FDA, EMA, Health Canada, and other regulatory authorities as necessary.
The company is a leading pharmaceutical organization focused on the development of late stage, metabolic based oncology therapeutics. By focusing on understanding the bio-energetic processes specific to cancer, this organization has made significant strides in the development of their products. One such drug targets enzymes that focus on cancer cell energy metabolism, and is currently being evaluated in Phase I, I/II, and II clinical studies.
The ideal candidate will have a background in CMC and Regulatory Affairs Strategy in order to participate and lead in negotiations with the appropriate regulatory authorities. Furthermore, they will have the dedication and passion to help this smaller organization continue to build upon their success and impactful oncology therapeutics products.
RESPONSIBILITIES:
* Act as lead for the development of regulatory strategy for the company by drawing upon background in Regulatory Affairs and CMC.
* Interact directly with FDA, EMA, Health Canada, and other regulatory agencies to facilitate the development process.
* Develop and oversee key regulatory documents such as IMPD, IB, IND, etc. while also providing responses to regulatory agencies regarding the company's clinical study submissions and drug development.
REQUIREMENTS:
* 15+ years of experience in biopharma industry with at least 10+ years of this focused within regulatory affairs and CMC.
* Masters/PHD in a relevant scientific or life sciences area of study.
* Previous experience leading phase 3 clinical trial submissions and the management of regulatory documents (IMPDs, INDs, NDAS, etc.)
* Previous experience acting in a management/directorial capacity.
* Experience with ASEAN Regulatory Authorities a plus.
* Specialized focus in the Regulatory Affairs needs of oncology drug/therapeutic development.
