about 1 year ago
A Biopharmaceutical client of ours is hiring an Executive Director of Global Regulatory Affairs to be based in New Jersey. This person will report to the Vice President of Global Clinical Development.
- Oversee all regulatory activities for the company
- Manage and oversee a team of Regulatory Affairs Professionals across various levels
- Be responsible for strategy relating to the global approval of NCEs and biosimilars in different markets
- Identify and coordinate educational trainings as needed and provide pertinent information on regulatory topics
- Work closely with management team to implement short and long-term business plans and goals
- Build a connected and collaborative department to keep up with the growth and evolution of the company
- 15 years of pharmaceutical/biotech experience in Regulatory Affairs
- Extensive knowledge of US and EU regulations
- Experience with a variety of regulatory submissions and regulatory agencies
- 5 years of experience supervising staff in the regulatory area
- Ability to work independently
- Superb oral communication and written skills
- Demonstrated ability to manage multiple projects, lead people in a productive manner, and develop positive relationships.
If this role is of interest to you, please send your CV to Marissa at firstname.lastname@example.org to apply.