Assoc. Dir, Regulatory Affairs

• For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities

. • Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.

• For assigned products ensures timely, accurate and compliant labeling review and artwork preparation.

• For assigned products and tasks, stays updated on late pipeline filings, relevant regional and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.