6 months ago
My client is a market lead in the biopharmaceutical space that addresses the significant unmet medical needs in rare diseases. My client is looking to hire a passionate Senior Director of Regulatory Affairs, who will report to the Vice President of RA, and will be responsible for the execution of all regulatory activities within his/her assigned area the organization along with the following:
- Conducting strategic advice/decisions, coordination, and leading the team efforts to result in timely regulatory global submissions.
- Being the company expert on both FDA and EMEA regulations.
- Representing the company to regulatory authorities.
- Proactively identifying constraints or possible risks to programs in terms of regulations.
- Staying abreast of current regulations and competitive intelligence.
- Mentoring the department personnel and updating appropriate departments on the current regulatory environment, and others as assigned.
- Being hands-on for project team requirements.
- Serving as the regulatory project team lead for a designated project and as such would be responsible for the production of all major US and EU filings.
The Position's Requirements Include:
- 15 years or more of regulatory experience in a pharmaceutical company.
- Minimum of Bachelors’ degree.
- Previous experience with U.S. and European regulatory authorities required. Experience with Japan is also a plus.
- Deep familiarity with the overall drug development process especially related to clinical trial requirements for submissions required.
- Experience with BLA/NDA filing a must; experience with other filings highly desirable- IND filings, PSPs, PIPs, orphan and breakthrough product applications.
- Preferred experience in Biologics.
- Previous mentorship experience of more junior regulatory staff.
- Familiarity with combination products of drug-device is a plus.
- Previous experience participating in FDA / EMEA or other regulatory meetings.
- Strong writing, communication, and presentation skills.
- Ability to travel internationally up to 20% of the time.
- Experience in Asia/pacific sector (i.e., Japan and Korea a plus).