Pharmaceutical company in Gaithersburg MD are hiring a Senior Regulatory Affairs Manager to join a new team for a growing business unit. In this role you will be responsible for leading the regulatory program for a variety of drug-device combination products for US and global markets.
As the Regulatory Affairs Senior Manager you will lead strategy and submission process for IDA and NDA filings, as the combination products as drug led. You would work with local and international teams to drive regulatory milestones and deliverables and be the main point of contact for FDA and other notified bodies globally.
It is an opportunity to work in an autonomous role and take the lead on a regulatory program to drive a global strategy for a new and growing business unit, with support from the group's Director.
- Establish and implement product related regulatory strategies and advising project teams on regulatory considerations.
- Leading submissions for clinical trials and market applications for combination product portfolio for US and global markets.
- Ensure all licenses required for clinical trials and approved commercial products.
- Management of changes to regulatory guidelines on a global basis.
- 10 years of experience with pharmaceutical regulatory affairs, small molecule or generics focused ideally.
- Minimum of 1 year experience with drug-device combination products.
- Experience with management of full IDA and NDA filing process.
If you are interested and meet the requirements please apply with your resume.
This is direct hire role where you would be required to be on site in Gaithersburg MD. There is a comprehensive relocation package available if you are not living locally now.
Salary is depending on experience level ranges from $150-180K base salary with additional bonus
Sthree US is acting as an Employment Agency in relation to this vacancy.