Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; Wakefield; Remote; GBP 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Senior Regulatory Affairs Manager to oversee NDA strategies for Emerging Markets. The role involves collaboration across teams to ensure successful product filings and launches, requiring a strong regulatory background and strategic leadership. The position is remote within the UK.

Responsibilities

• Manage communication and implementation of NDA strategies for Emerging Markets.
• Develop regulatory strategies, collaborating with cross-functional teams.
• Serve as Regional Strategy lead, providing insights and participating in launch activities.

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 closely 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 a Regional Strategy lead in the RPT for assigned products, providing regional insights and participating in cross-functional forums and launch meetings.

About Planet Pharma:

Planet Pharma is an American-based Employment Business/Agency with global staffing services, headquartered in Chicago and regional office in Central London. We operate in over 30 countries with a network of 2500+ contractors and offer permanent and direct hire recruitment services.

Recognized by FORBES as the 17th best professional staffing firm, we have received multiple industry awards. 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/belief, sexual orientation, or age.