Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; Stevenage; Remote; GBP 70,000 - 100,000; Full time

Job summary

A global pharmaceutical company is seeking a Senior Regulatory Affairs Manager for Emerging Markets. This remote role focuses on managing NDA strategies and working closely with various regulatory and commercial teams to ensure successful product launches. The ideal candidate will have strong experience in regulatory affairs within diverse markets.

Qualifications

• Experience in regulatory affairs, particularly in emerging markets.
• Skilled in developing regulatory strategies and collaboration with various teams.
• Proficient in managing NDA submissions and market launches.

Responsibilities

• Manage NDA filing and strategies for products in Emerging Markets.
• Collaborate with cross-functional teams for optimal launch strategies.
• Participate as Regional Strategy lead in regulatory forums.

Skills

Regulatory Affairs

Communication

Collaboration

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 assigned products in these regions. Work closely with partners, affiliates, supply chain, PV, commercial, and medical colleagues to determine optimal NDA filing and launch strategies. Ensure timely delivery in partnership with CRO.
3. Participate as a member of RPT as Regional Strategy lead, providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is a global staffing services provider with headquarters in Chicago and an EMEA regional office in Central London. Recognized by FORBES as the 17th best professional staffing firm, we offer expertise in Regulatory Affairs, Pharmacovigilance, QA, QC, Clinical Development, and more. We are committed to diversity and welcome applications from all qualified candidates.