Project Manager – Pharmaceutical Regulatory Affairs
The Weinberg Group, a ProPharma Group Company, is the leading provider of regulatory and compliance services to the pharmaceutical, biotech, and medical device industries.
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Weinberg Group is currently searching for a new Project Manager – Pharmaceutical Regulatory Affairs to join their team. The Project Manager will have oversight of FDA regulatory affairs projects and are responsible for managing client expectations, watching timelines and budgets, and keeping abreast of client needs.
The PM will also need a solid understanding of FDA submissions and working with the FDA.
Essential Functions Include:
- Drive the project toward its deliverable due dates.
- Understanding of the technical issues of the project(s).
- Writing parts of projects and participate in strategy and deliverable development.
- Lead in preparing FDA submissions
- Leading the team as it prepares for FDA meetings.
- Advising clients on FDA matters as needed.
Qualified candidates must have:
- A degree in science or regulatory affairs, preferably an advanced degree.
- Minimum 7 years of experience in the pharma/biotech industry.
- Previous experience leading and driving projects to meet deadlines and budgets.
- Knowledge of basic FDA principles.
- Previous experience with knowing how to find and interpret FDA guidance.
- Excellent communication skills and client-facing skills.
- Direct experience in FDA – Sponsor meetings.
- Pharmaceutical development, pre-approval regulatory experience.
- An advanced degree in science and/or Regulatory Affairs.
- Experience with 505(b)(2) submissions.
- Consulting experience in Regulatory Affairs.
- Broad experience across a variety of therapeutic areas.
- All candidates must be legally eligible to work in the United States.
- We are an equal opportunity employer. M/F/D/V
- ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Learn more here
Job posted: 2020-07-30