Regulatory Affairs Manager II – London

Priya Mukherjee at CK Clinical is currently recruiting for a contract Regulatory Affairs, Emerging Markets Manager to work for a leading organisation in London.

The job:

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.

Key Responsibilities:

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:

Apply online now:

For more information or to apply for this Regulatory Affairs Manager II role please contact Priya Mukherjee on +44 (0)1438 743047 or email pmukherjee@ckclinical.co.uk

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