Director, Regulatory Affairs

Teva Sicor Pharmaceuticals is a global leader in the manufacture of generic injectable pharmaceuticals. Now a member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs, TEVA Sicor has an excellent opportunity for Director, Regulatory Affairs.

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.

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.
* Hires, manages, and trains Regulatory Affairs staff, conducts performance reviews, handles dispute resolution, enforces Human Resource policies within the department, etc.
* Follows Teva Safety, Health, and Environmental policies and procedures.
* Other duties, as assigned, or as business needs require.

Primary Outcomes:
* 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.
REQUIREMENTS
Requirements:
* Education Required: Minimum Bachelor’s degree in scientific or healthcare discipline, or equivalent combination of education and related experience.
* Education Preferred: M.S., Ph.D., R.Ph., Pharm.D. degree or equivalent combination of education and related experience. RAPS RAC (U.S. or EU)
* Experience Required: 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.
* Experience Preferred: Understanding of international regulatory requirements.
Specialized or Technical Knowledge, Licenses, Certifications needed: RAC certification is beneficial, but not mandatory. Knowledge of the chemistry, manufacturing and controls process for sterile injectable products.

As a new member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.

TEVA Sicor offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com. Click Employment Opportunities, then Positions Available and search for Position # 5132. You may also fax your resume to 949-458-8945.