Associate Director, Global Regulatory Affairs
Our client is a global pharmaceutical company. They have asked us to assist them in their search for a Associate Director, Global Regulatory Affairs
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Serves as Global Regulatory Lead (GRL) for assigned products in the Neurology Portfolio.
- Leads the planning, execution and assessment of product life cycle management activities from early development through post-approval.
- Proactively creates regulatory strategies that provide for streamlined development and approval timelines.
- Accurately interprets and reflects regulatory and Corporate guidelines in regulatory strategies.
- Leads the planning, preparation for and conduct of meetings with Health Authorities for all assigned products.
- Initiates and responds to Health Authority contacts to ensure expedient and efficient review and approval of products.
- Leads creation of all documents submitted to Health Authorities.
- Ensures all documents submitted to Health Authorities have been evaluated and that they are complete, well organized, scientifically accurate, of high quality, and in regulatory compliance.
- Identifies, monitors and resolves regulatory issues and reporting progress to management.
- Guides project teams in the implementation of appropriate regulatory strategies and in the assessment of regulatory support needs.
- Aligns resources as Chair of the Global Regulatory Subteam.
- Leads and coordinates all regulatory activities required for submissions to Health Authorities for assigned products.
- This role has the potential to manage a direct report based on business needs.
- Bachelor’s degree in the sciences or health related field required.
- Advanced degree highly preferred.
- Must have a minimum of 6 years of pharmaceutical industry experience in regulatory strategy.
- Demonstrated knowledge of drug development process and strategic thinking skills are required.
- Requires knowledge of US and global regulations and specific Health
- Authority guidance documents.
- Must have experience with preparing IND/CTA submissions and briefing packages for Healthy Authority meetings.
- Experience with successful NDA, sNDA and/or BLA filings highly preferred.
- Requires the ability to bring divergent views together to align on common objectives.
- Requires the ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Prior experience working with the global Health Authorities is highly preferred.
- The demonstrated ability to solve complex problems is required.
- Must be able to travel approximately 10% travel based on business needs.
If interested, please email your resume as a Word attachment to us. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.