Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; Reading; Remote; GBP 60,000 - 85,000; Full time

Job summary

A leading company is seeking a Senior Regulatory Affairs Manager specializing in Emerging Markets. The role involves managing regulatory strategies and communication for NDA filing and product launches across diverse regions, ensuring coordination with various teams. Join a global team recognized for its commitment to excellence in regulatory affairs.

Responsibilities

• Manage communication and implementation of NDA strategies for Emerging Markets.
• Develop regulatory strategies for optimal NDA filing and launch.
• Serve as Regional Strategy Lead within cross-functional forums.

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 local regulatory teams.
2. Develop and deliver regulatory strategies for assigned products, 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. 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 a US-based employment agency with headquarters in Chicago and an EMEA regional office in London. We operate in over 30 countries, supporting more than 2,500 contractors globally, with a strong focus on regulatory affairs and related fields. Recognized by Forbes as a top professional staffing firm, we are committed to diversity and equal opportunity employment.