Vice President, Regulatory Affairs

Responsible for: setting strategic regulatory affairs direction working with executives at company, leading the interface with the FDA and international regulatory agencies, participation in due diligence efforts aimed at evaluating potential product/company acquisition candidates, and oversight and management of regulatory affairs activities.

PRIMARY RESPONSIBILITIES

Recommend and manage regulatory affairs strategy including labeling negotiations with the FDA, FDA interactions including advisory panel meetings, submissions, REMS programs, clinical trials (both company sponsored and investigator initiated studies), etc.

Manage all regulatory activities including (i) preparation, review and submission of regulatory submissions (IND, 505(b)2, NDAs, (ii) marketed products promotional materials, (iii) regulatory documentation maintenance, and (iv) corporate relations with regulatory agencies. Represent company at regulatory agencies (domestic and international). Responsible for internal regulatory support to ensure regulatory compliance.

Review, approve, and submission of all marketing promotional materials and labeling to ensure regulatory compliance.

Ensure the most current FDA regulatory requirements and policies are understood and integrated into the company.

Develop and manage project plans and timelines for regulatory submissions.

Advise senior management on regulatory issues related to new business, new products, etc.

Requirements:

BS/MS/PhD degree in a scientific discipline or equivalent, with a minimum of 15 years regulatory affairs experience in the pharmaceutical/biotechnology industry in which commercial products were manufactured, distributed, and marketed with 5+ years experience as head of regulatory affairs at the Vice President level.

Strong knowledge of FDA regulations and guidelines, and pharmaceutical industry practices and policies.

Proven track record in setting and managing regulatory strategy.

Experience managing domestic and international regulatory consultants is desired.

Strong technical writing and verbal communication skills.

Excellent planning and organizing skills.

Hands-on, results oriented, and team player.