regional Regulatory hub strategist (im/i&i)Pfizer

Job Description : JOB SUMMARY To support or manage projects and product-related registration strategies in the assigned therapeutic categories/countries. . Single point of contact for GRA-I Asia and PCO team on regional issues. . To ensure that regu Job Description : JOB SUMMARY To support or manage projects and product-related registration strategies in the assigned therapeutic categories/countries. . Single point of contact for GRA-I Asia and PCO team on regional issues. . To ensure that regulatory documentation meet relevant regulatory requirements. . To apply knowledge and interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration and lifecycle license maintenance of of medicinal products consistent with the supported regions commercial objectives. . Provide support to ensure efficient engagement between Global/Regional Regulatory Strategists, relevant partner lines and Regulatory PCO staff as a Single Point of Contact (SPOC) for assigned products to ensure business continuity. . To build local relationships and ensure communication/clarity of regulatory timelines and strategy QUALIFICATION . Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential. . Appropriate Regulatory Experience - minimum 3-6 years experience (Job Grade specific). . Proven ability to manage complex regulatory or drug development issues. . Proven ability to consistently deliver to time, cost and quality standards. . Fluent in English - written and spoken communication skills . Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred. . Proven performance track record - country and/or regional. . Country/regional knowledge (Asia) #LI-PFE Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs#LI-PFE
Monster

Makati City, Metro Manila
Permanent
Full-time