Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; Newcastle upon Tyne; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading company seeks a Senior Regulatory Affairs Manager for a remote role focusing on emerging markets. You will manage and deliver regulatory strategies for products, ensuring compliance and collaboration with global teams. This full-time contract position offers the opportunity to leverage your expertise in regulatory affairs and emerging markets within a dynamic pharmaceutical environment.

Qualifications

• Experience in Emerging Markets, including MEA, TCR, and CEE.
• Strong background in managing NDA and line extension strategies.
• Ability to work with regulatory teams and understand market-specific requirements.

Responsibilities

• Manage communication and implementation of NDA strategies.
• Develop regulatory strategies and collaborate with teams for optimal delivery.
• Contribute as Regional Strategy Lead in cross-functional meetings.

Skills

Regulatory Strategy Development

Cross-Functional Collaboration

Emerging Markets Knowledge

Job description

Role: Senior Regulatory Affairs Manager - Emerging Markets

Location: Remote, UK

Company: Global Pharmaceutical

We are currently seeking a Senior Regulatory Affairs Manager with experience in Emerging Markets, including Middle East Africa (MEA), Turkey, CIS & Russia (TCR), and Central Eastern European Markets (CEE). This is a 12-month full-time contract role.

Responsibilities:

1. Manage communication, development, and implementation of NDA and major line extension strategies for assigned products in Middle East Africa (MEA), Turkey, CIS & Russia (TCR), and CEE, collaborating with global, regional, and in-country regulatory teams.
2. Develop and deliver regulatory strategies for assigned products in the specified regions, working with partners, affiliates, supply chain, PV, commercial, and medical teams to determine optimal NDA filing and launch strategies, ensuring timely delivery in partnership with CRO.
3. Participate as a member of the RPT as Regional Strategy Lead for assigned products, providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is an American-based employment business and agency, providing global staffing services. Headquartered in Chicago with an EMEA regional office in Central London, we operate compliantly in over 30 countries with a network of 2,500+ active contractors and a strong permanent recruitment offering.

Recognized by FORBES as the 17th best professional staffing firm, we have received multiple industry awards for excellence. Our expertise spans Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions, Clinical Development, Quality, Biostatistics, and Medical Affairs/Writing.

We are committed to equal opportunities and welcome applications from all qualified candidates regardless of race, sex, disability, religion, sexual orientation, or age.