Senior Regulatory Manager (Growth Markets).

Employment Type

: Full-Time

Industry

: Miscellaneous



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Advanced Resource Managers are looking for a Senior Regulatory Affairs Manager (Growth markets) to join our client who are based on the border of New Jersey/New York. This post will be working closely with regulatory partners to support the development and implementation of regulatory strategies to allow timely submissions and approvals. The role will also focus within the product life cycle management activities and strategies. You will be encouraged to expand your current knowledge within Growth/emerging markets and will be a point of contact to create high-quality dossiers to enable effective registration processes which are aligned to the commercial objectives of the business. Main responsibilities of the role would be as follows –. Contribute to the planning, execution, and assessment of product life cycle management activities and strategies. Contribute to the development and implementation of regulatory strategies for the assigned projects and escalating issues when needed. Working closely across various teams to deliver complete regulatory submissions within agreed timeframes. When needed you will be interacting and negotiating with health authorities with the assistance of the team. Qualifications. BS/BA in Life Sciences in a relevant field with minimum 5 years of broad pharmaceutical industry experience, including 3 years of experience with new/innovative drug registration strategy/submissions, or. MS with 4 years of broad pharmaceutical experience including 2+ years of experience with new/innovative drug registration strategy/submissions. Previous experience in emerging/growth markets within international regions would be preferred. Strong understanding of the drug development process as well as working knowledge of relevant drug laws, regulations and guidance’s/guidelines. Experience in leading team discussion to resolve and reach agreement on project issues. If you are interested in this role please contact Vik Patel on 00442392 458031 or email me on vik.patel@arm.co.uk.

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