Regulatory Affairs Director - Biotech - Lexington, MA
Based in Lexington, MA
Head of regulatory affairs for the USA
About Our Client
Global bio-tech company with US operations based in MA.
Global bio-tech company based in MA seeks Regulatory Affairs Director to be based at their US headquarters and spearhead their US compliance operations. Main duties and responsibilities are:
- Direct day to day regulatory affairs activities, including reviewing promotional materials, participating in submissions to and interaction with the FDA
- Working alongside the wider Global Regulatory Affairs team, direct all USA domestic regulatory projects
- Perform regulatory review of manufacturing, quality, research & development and commercial documents
- Provide commentary and feedback and assume responsibility for regulatory approval for relevant documents
- Monitor trends and changes in the wider regulatory environment
- Work with internal stakeholders to ensure that all relevant company activities are in conformance and compliance with regulatory law and guidance.
Submit resume today for consideration within 48 hours.
The Successful Applicant
In return for a competitive remuneration package, the successful candidate will possess the following:
- 4 to 8+ years of experience in bio-tech regulatory affairs
- Work experience of working with vendors and closely with the FDA
- Hands on experience
- Ability to travel extensively, both nationally and internationally
What's on Offer
- Base salary of $ 150,000 to $ 170,000 base salary
- Performance related bonus scheme
- Competitive benefits