Dir, Sr Regulatory Affairs - Allergan (santabarbara, CA)

Title: Dir, Sr Regulatory Affairs 1. Submissions: : Independently plans and prepares complex regulatory documents for product approval. : Independently resolves submission problem areas. : Independently prepares complex expository and technical documents, logically constructed and comprehensive in content. : Ensures effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance in all markets 2. Advisory Responsibilities: : Participates in and/or leads global teams. : Collaborates and advises the team on resolution complex project issues. : Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements. : Evaluates opportunities for accelerated approval and/or early access to products in development : Defines regulatory requirements for initiatives in support of regional business needs 3. Communications: : Prepares documentation that is complete, accurate, and on time. : Delivers business and educational presentations within the Company as required. 4. Regulatory Compliance: : Approves manufacturing process changes as appropriate. : Reviews promotional, advertising, labeling and packaging components to ensure accuracy and compliance with governmental regulations. Education and Experience Education equivalent to a BS degree in a scientific field, plus 13 years experience in regulatory affairs; or MS degree in a scientific field, plus 11 years experience in regulatory affairs; or a PhD degree in a scientific field, plus 8 years experience in regulatory affairs Class III medical device experience required. 10 years of increasing responsibilities in management of health care product development including regulatory affairs. Significan Source:

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