Director of Regulatory Affairs
: Job Details :

Director of Regulatory Affairs - Full Time - Onsite/Hybrid/Remote

12 Months Contract - 20-30 hours a week. URGENT NEED - ROLE WILL BE FILLED WITHIN 24 HOURS DO NOT HESITATE TO APPLY.

About the Role:

Accepting applicants in California, ideal candidate can work on site, but may be remote with some travel within California.

The Director will work closely and report to the Head of Regulatory Affairs. You will provide regulatory advice and guidance across the company for product development and strategies for market approval in line with business goals and European, US and international regulations.

Responsibilities:

• Implement strategy through the the regulatory team for assigned products across all phases of product development.
• Operate cross-functionally to prepares INDS, CTAs, briefing documents, NDAs and MAAs as required.
• Identify risks and develop solutions to the identified risks, assess the probability of success for the solutions.
• Regulatory reports to management.
• Represent the company at regulatory agencies for products assigned, planning and conducting meetings, ensuring that the documents submitted are compliant.
• Work closely with the Head of Regulatory Affairs to achieve company goals.
• Independently, Provide guidance to colleagues, management, and stakeholders to ensure regulatory success.
• Any other regulatory affairs tasks assigned or required as per the business needs.

Desired Experience:

• Bachelors Degree in a science (E.g. Biology, Chemistry, Pharmaceutical).
• 8+ Regulatory affairs experience in small molecule (preferred) or biologics development.
• Proven experience in implementing strategic development to new drug development.
• Proven track record of success in development, submission and registration of new drugs.
• Rare disease, Gastroenterology and pediatric drug development experience highly desired.

This job requires legal authorization to work in the US. We are not currently accepting work visas.

Apply now by submitting your CV.

Reach out for a call to discuss your experience and how you would fit into this role.

...@barringtonjames.com

If you are interested, get in touch with me ASAP by simply applying below.

You can also send your most up to date CV directly to me, and I will reach out to you.

Jean-David Mandarin – Clinical Associate Recruiter

Email – ...@barringtonjames.com