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103525 - Regulatory Leader, - Vice President, Regulatory Affairs

Company:
inVentiv Health Clinical
Location:
Washington, District of Columbia, United States
Posted:
February 13, 2018
Description:

Position Overview

The Vice President, Regulatory Affairs, Pharmaceuticals and Biologics will be a critical team member reporting directly to the Senior Vice President of Clinical & Regulatory Affairs, to support regulatory strategy and submissions for the firm’s clientele. The ideal candidate must have in depth experience and knowledge of pharmaceutical and biologic products and the associated regulatory pathways to get these technologies through FDA approval. Further, he or she also must have excellent communication and entrepreneurial skill sets to be a lead consultant and manager for the firm’s pharmaceutical consulting practice as it is a new practice area for the firm.

Requirements

• Minimum of 12 20 years of experience in Regulatory Affairs related to development of pharmaceuticals and biologics

• MS or PhD in a scientific discipline or MD

• Attention to detail and the ability to work individually, within a multi disciplinary team, as well as with external partners and vendors.

• Possesses strong written and verbal communication and presentation skills.

• Experience developing or reviewing regulatory submissions to the Food & Drug Administration, preferably INDs, NDAs, and BLAs as well as post submission application support

• Expertise in chemistry/manufacturing/control, toxicology, pharmacokinetics, statistics, clinical medicine, medical writing, regulatory science, project management and document publication

• Strong research, analytical and problem solving skills

• Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently

• Knowledge and experience utilizing research and providing statistical analysis

• Effective interpersonal skills: strong professionalism, shows confidence with subject matter and “calm under pressure” approach and style, with internal team members and with customer relationships

• Measureable experience working with C Level and senior management

• PC/Technical skills MS Office, Excel, Word, PowerPoint

Job Description

• Work with other department heads and the general manager to guide progress and development of the regulatory department and company as a whole, particularly as it relates to building COMPANY’s experience and services for pharmaceuticals, biologics, and drugs

• Assist in building and managing appropriate regulatory, clinical, and scientific team for various products and associated regulatory/clinical needs

• Management of scientific and regulatory team

• Team player who will work collaboratively and integrate projects with COMPANY’s regulatory, clinical, quality assurance, and reimbursement divisions

• Develop and execute regulatory services for client companies, including however not limited to:

o Regulatory Submissions (IND, BLA, & NDA)

o Regulatory Strategy, Analysis & Development

o Review & Strategize Non Clinical Testing related to pharmaceutical

development

o Pre clinical and clinical strategies

• Perform business development functions to secure new clients and projects