Our client is commercializing and distributing Women’s and Men’s Health treatments. They are seeking a Regulatory Affairs Senior Director (Contractor/Consultant) who can provide Regulatory strategy and execution for their portfolio of pharmaceutical products. Reporting into the President and CEO of the company, you will be responsible for regulatory strategy and compliance, while leading interactions with FDA. This is a hybrid position and candidates in the New Jersey area are preferred. This engagement will be approximately 40 hours per week for about three months, or until their FTE Head of Regulatory position can be filled.
Responsibilities:
- Work closely with teams to define and execute on the optimal regulatory strategy for submissions and approval pathways.
- Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical products in order to control the safety and efficacy of the products.
- Ensure that products comply with the regulations of all applicable regulatory agencies.
- Stay current and apprised of changing U.S. legislation, guidelines and customer practices.
- Develop and write clear processes for Regulatory approvals.
- Oversee submissions of license variations and renewals.
- Monitor and set timelines for license variations and renewal approvals.
- Work with marketing to approve commercial literature and language.
- Review company practices and provide advice on changes to systems.
- Keep abreast of new or developments in various regulations and advice senior management as necessary.
- Supervise the creation of company SOPs.
- Oversee the compliance training and educational programs for employees.
- Design and conduct health care compliance auditing program including audits of reps and speaker program.
- Upon completion of audits, recommend resolution of compliance issues and ensure integrity of the compliance program
- Consult with management on potential compliance risk areas.
- Conduct internal investigations, as necessary, and document investigation steps, findings, and remedial actions
Qualifications:
- Bachelor degree in a life science. Advanced degree (MS, PhD, etc) preferred.
- Minimum of 12+ years of experience in a Regulatory Affairs for pharmaceutical drugs.
- Must have strong experience leading Regulatory filings and working directly with FDA.
- Experience with Schedule III controlled substances a plus but not required.
- Must be familiar with manufacturing techniques, project management and formal continuous process improvement techniques.
- Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including the Anti-Kickback Statute, False Claims Act, FCPA, PhRMA Code, OIG Guidance, FDA Regulatory Guidelines, FCPA, Federal Sunshine act, state marketing disclosure laws, and state price reporting statutes.
- Must be flexible and comfortable with ambiguity in a small company environment.
- Excellent verbal and written communication skills.
- Team-oriented individual with strong interpersonal skills. Excellent organizational skills, and a good blend of discipline and creativity.
This is a hybrid position and our client prefers candidates in the New Jersey area who can come into the office regularly.
Note: All contractors must be authorized to work in the United States. H1B sponsorship is not available.