Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; Hemel Hempstead; Remote; GBP 50,000 - 85,000; Full time

Job summary

A global pharmaceutical company is seeking a Senior Regulatory Affairs Manager to support the delivery of regulatory strategies in Emerging Markets, including MEA and CEE. This full-time role involves collaboration across multiple teams to ensure timely NDA filings and launches. Ideal candidates will have substantial experience in regulatory affairs within these regions.

Responsibilities

• Manage communication, development, and implementation of NDA strategies for assigned products in MEA, TCR, and CEE.
• Develop and deliver regulatory strategies for assigned products in these regions.
• Participate as a Regional Strategy lead in the RPT for assigned products.

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 full-time, initial 12-month contract role.

Responsibilities:

1. Manage communication, development, and implementation of NDA and major line extension strategies for assigned products in MEA, TCR, and CEE, collaborating with global, regional, and local regulatory teams.
2. Develop and deliver regulatory strategies for assigned products in these 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 Regional Strategy lead in the RPT 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 agency with headquarters in Chicago and an EMEA regional office in Central London. We operate in over 30 countries, supporting more than 2,500 active contractors globally, with 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 an equal opportunity employer and welcome applications from all qualified candidates regardless of race, sex, disability, religion, sexual orientation, or age.