Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; Wolverhampton; Remote; GBP 60,000 - 90,000; Full time

Job summary

A leading global pharmaceutical company is seeking a Senior Regulatory Affairs Manager to oversee NDA strategies for Emerging Markets, including MEA, Turkey, and CIS. This remote role requires collaboration across various teams to ensure optimal filing and launch strategies.

Responsibilities

• Manage communication, development, and implementation of NDA strategies for Emerging Markets.
• Develop and deliver regulatory strategies, ensuring timely delivery in partnership with CRO.
• Serve as Regional Strategy Lead for assigned products, providing regional insights.

Job description

Role: Senior Regulatory Affairs Manager - Emerging Markets

Location:

Remote, UK

Company:

Global Pharmaceutical

Responsibilities:

1. Manage communication, development, and implementation of NDA and major line extension strategies for assigned products in Emerging Markets including 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 these markets, working with partners, affiliates, supply chain, PV, commercial, and medical colleagues 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 the RPT, providing regional insights and participating in cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is an American-owned employment business providing global staffing services, headquartered in Chicago with an EMEA office in Central London. We operate compliantly 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 hold multiple industry awards. 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/belief, sexual orientation, or age.