Director, Regulatory Affairs

Excellent opportunity for a Director of Regulatory Affairs with a leading pharmaceutical company located in the Irvine area!

Position Summary:
The Director, Regulatory Affairs, is primarily responsible for establishing the regulatory affairs strategy associated with the product development cycle of sterile injectable products. In addition, the responsibility extends to managing the Regulatory Affairs department to assure that the department accomplishes its functions adequately and has resources to meet company objectives. Also provides leadership with regard to regulatory affairs best practices in the sterile injectable arena.

Job Duties/Responsibilities:

Establishes and communicates Regulatory Affairs strategies and tactics for sterile injectable products to meet company and corporate objectives.

Acts as primary contact representing Regulatory Affairs for the site for both government and business interactions, possessing signature authority as the company's Regulatory Affairs authority.

Manages all projects assigned to the Regulatory Affairs department and the associated budget approved by the company.

Advises company and corporate management on Regulatory Affairs matters as requested and when changes occur in the regulatory landscape with potential impact to the business.

Delivers application submissions, application approvals, and product launches meeting timelines established by company and corporate objectives.

Maintains compliance of applications to allow uninterrupted commercial distribution of approved sterile injectable products in the company portfolio.

Influences regulatory policy to benefit the company.

Effectively communicates Regulatory Affairs issues to allow for better business decisions to be made.

Establishes a Regulatory Affairs department with depth of competency in Regulatory Affairs and breadth in sterile injectable product development.

Hires, manages, and trains Regulatory Affairs staff, conducts performance reviews, handles dispute resolution, enforces Human Resource policies within the department, etc.

Follows company Safety, Health, and Environmental policies and procedures.

Other duties, as assigned, or as business needs require.

Experience:

Minimum of a Bachelor's degree in scientific or healthcare discipline, or equivalent combination of education and related experience.

Prefer M.S., Ph.D., R.Ph., Pharm.D. degree or equivalent combination of education and related experience. RAPS RAC (U.S. or EU)

Minimum of 8 years in pharmaceutical regulatory affairs with an advanced understanding of the regulatory requirements for DMFs, INDs, ANDAs, and NDAs. 5 years supervisory experience.

Understanding of international regulatory requirements preferred.

Specialized or Technical Knowledge, Licenses, Certifications needed: RAC certification is beneficial, but not mandatory.

Prefer knowledge of the chemistry, manufacturing and controls process for sterile injectable products.




job Requirements


Please refer to the job description above.