Priya Mukherjee at CK Clinical is currently recruiting for a contract Regulatory Affairs, Emerging Markets Manager to work for a leading organisation in London.
As a Regulatory Affairs Manager II you will use expertise in emerging markets to provide input into product strategy for the region, preparing International Market Applications for new products, reviewing post-marketing variations and leading the preparation of responses to agency questions.
The key responsibilities of this Regulatory Affairs Manager II role are:
• Manage execution of product strategies for assigned MAA and variations.
• Interface with regional regulatory, EM commercial and Operation to develop specific strategies for activities that impact the EM region.
• Keep abreast of changes in legislation and understand the impact on current and future submissions.
• 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 EM product Lead
• Provide guidance on regional regulatory mechanisms to optimize product registration
• Work with Emerging Markets Product Lead to assess the impact of variations across EM 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 EM
• Troubleshoot and resolve any problems on the critical path to registrations in concert with the key stakeholders
• Lead the preparation and respond to questions raised by authorities within region
Qualifications and skills:
Interested applicant for this Regulatory Affairs Manager II role should hold:
• Bachelors degree, OR equivalent combination of education and experience
• Significant proven regulatory experience
• Strong knowledge and experience within Emerging Markets
• Ability to work within a dynamic matrix environment
• Strong proven leadership skills, with the ability to take responsibility, make informed decisions and direct the activity of others in matrix, internal or external reporting relationships
• The ability to work with policies, procedures and SOP’s
• Proven experience with national legislation and regulations relating to medicinal products
• An understanding of the registration procedures in the EM region for MA, post approval changes, Line extensions and renewals for Medicinal products.
• An understanding of drug development
How to apply:
For more information or to apply for this Regulatory Affairs Manager II role please contact Priya Mukherjee on +44 (0)1438 743047 or email firstname.lastname@example.org