Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; City of Edinburgh; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading company is looking for a Senior Regulatory Affairs Manager focusing on Emerging Markets. This remote position will involve managing NDA strategies and collaborating with diverse teams across multiple regions, providing a unique opportunity to influence product launches effectively.

Responsibilities

• Manage communication and development of NDA strategies for assigned products.
• Develop regulatory strategies for MEA, TCR, and CEE markets.
• Serve as Regional Strategy Lead within cross-functional teams.

Job description

Role: Senior Regulatory Affairs Manager - Emerging Markets

Location: Remote, UK

Company: Global Pharmaceutical

We are currently looking for 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 role is a 12-month full-time contract.

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 Central Eastern European Markets (CEE). Collaborate with global, regional, and in-country regulatory teams.
2. Develop and deliver regulatory strategies for assigned products in these regions. Work 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. Serve as Regional Strategy Lead for assigned products within RPT, providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is a US-based employment business providing global staffing services, with headquarters in Chicago and an EMEA regional office in London. We operate in over 30 countries with a network of 2,500+ contractors and offer permanent and direct hire recruitment services.

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 opportunity employment and welcome applications from all qualified candidates regardless of race, sex, disability, religion, sexual orientation, or age.