Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A global pharmaceutical company seeks a Senior Regulatory Affairs Manager for Emerging Markets. This remote, full-time role involves managing NDA strategies, coordinating with various teams, and providing insights for product launches. Applicants should have experience in regulatory affairs and a background in the pharmaceutical industry.

Responsibilities

• Manage communication, development, and implementation of NDA and major line extension strategies.
• Develop and deliver regulatory strategies for assigned products.
• Serve as Regional Strategy Lead for assigned products within the Regulatory Product Team.

Job description

Role: Senior Regulatory Affairs Manager - Emerging Markets

Location:

Remote, UK

Company:

Global Pharmaceutical

Duration:

Initial 12-month contract, full-time

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, coordinating 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 Regulatory Product Team (RPT), providing regional insights and participating in cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is a global staffing services provider headquartered in Chicago with a regional office in Central London. Recognized by FORBES as the 17th best professional staffing firm, we offer expertise across regulatory affairs, pharmacovigilance, QA, QC, clinical development, and more. We are committed to equal opportunity employment and welcome applications from all qualified candidates.