What are the responsibilities and job description for the Associate Director Regulatory Affairs position at Proclinical Staffing?
Associate Director, Regulatory Affairs – Permanent – Georgia or North Carolina
Proclinical is seeking an Associate Director, Regulatory Affairs for a successful and growing global biopharmaceutical company with locations in Georgia and North Carolina.
Primary Responsibilities:
In this role, you will be responsible for all regulatory activities related to product development and marketing authorizations in the US and is the primary contact point within the company for any regulatory issues with the product and with designated health authorities. You will successfully collaborate & partner with members of the US Regulatory Affairs department within the Neurology therapeutic area.
The position can be based in Georgia or North Carolina in a hybrid work schedule.
Skills & Requirements:
- Minimum of a Bachelor’s degree: Master’s degree preferred.
- A minimum of 5 years of progressive experience in the Pharmaceutical, Biotechnology and/or CRO industry is required.
- 10 years pharmaceutical experience in Regulatory Affairs preferred.
- Demonstrated experience building effective partnerships:
- Identifies opportunities and takes actions to build effective relationships within and across teams with appropriate use of interpersonal skills and sensitivity to diverse cultures comprising the global work environment.
The Associate Director, Regulatory Affairs will:
- Develops and implements the regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the Global Regulatory Lead.
- Responsible for ensuring that the regional regulatory strategy for the specific product(s), have been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified and mitigated.
- Deliver regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
- Assist in development of regulatory standards, efficient processes and SOPs.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at ( 1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
