Job Summary
The role of the Regulatory Affairs Manager within Emerging Markets is to facilitate product global registration and life cycle management by executing regulatory strategies for initial product registration and throughout product lifecycle
Responsibilities:
Use expertise in IE markets to provide input into product strategy for the IE region
Preparation of International Market Applications for new products
Review of post-marketing variations (labelling and CMC)
Generation ofresponses to agency questions. This includes:
Manage execution of product strategies for assigned MAA and variations
Interface with regional regulatory, IE commercial and Operation to develop specific strategies for activities that impact the IE region
Keep abreast of changes in legislation and understand the impact on current and future submissions
The ideal candidate will be proficient at a managerial level in the following activities. Experience should be substantial and recent
Key Activities:
Execute successful marketing application within region
Liaise with CMC and support the execution of labelling variations in region
Reports status of assigned registration and life cycle management activities and projects to IE product Lead
Provide guidance on regional regulatory mechanisms to optimize product registration
Work with IE Product Lead to assess the impact of variations across IE region
Actively contribute to product strategy for assigned markets
Track status Marketing Authorizations Applications and Variations submissions and approvals
Advocate and actively support regulatory and safety compliance for products supplied across IE
Troubleshoot and resolve any problems on the critical path to registrations in concert with the international product Lead
Lead the preparation of responses to questions raised by authorities within region
Qualifications
Bachelors degree, or equivalent combination of education and experience
Masters or Doctoral degree advantageous
Regulatory Affairs, Development, Quality/Compliance or related area in the pharmaceutical/biotechnology, OTC or medical device industry
Preferred experience with registration of products in the following markets: Latin America, Middle East Africa (MEA), Central Eastern Europe and Asia Pacific
Experience with providing technical and/or managerial support for the creation, review, and finalization of components of
Marketing Applications as well as license maintenance regulatory submissions for the above regions
Drug development (Non clinical, clinical and CMC aspects)
Detailed understanding of regional regulatory hurdles and strategic registration options
General understanding of individual market authority operations and submission processes
In-depth disciplinary knowledge