Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A leading company in the pharmaceutical sector is seeking a Senior Regulatory Affairs Manager for Emerging Markets. The role focuses on managing NDA strategies and regulatory compliance across various international markets, offering a full-time remote opportunity for a skilled professional. Ideal candidates will have extensive experience in regulatory affairs and a proven track record in emerging markets.

Qualifications

• Experience in Emerging Markets, including MEA and CEE.
• Strong background in regulatory affairs and NDA management.
• Ability to collaborate with global and regional teams.

Responsibilities

• Manage NDA and major line extension strategies for emerging markets.
• Develop regulatory strategies in collaboration with various teams.
• Participate as a Regional Strategy lead in cross-functional forums.

Skills

Communication

Regulatory Strategy Development

Collaboration

Job description

Role: Senior Regulatory Affairs Manager - Emerging Markets

Location: Remote, UK

Company: Global Pharmaceutical

We are currently looking for a Senior Regulatory Affairs Manager with experience in Emerging Markets including Middle East Africa (MEA), Turkey, CIS & Russia (TCR), and Central Eastern European Markets (CEE). This role will be an initial 12-month full-time contract.

Responsibilities:

1. Manage communication, development, and implementation of NDA and major line extension strategies for assigned products in MEA, TCR, and CEE markets, working closely with global, regional, and in-country regulatory teams.
2. Develop and deliver regulatory strategies for assigned products, collaborating 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. Participate as a Regional Strategy lead in RPT for assigned products, providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is an American-based employment agency offering global staffing services, with headquarters in Chicago and an EMEA office in Central London. We operate in over 30 countries with a network of 2500+ active contractors and specialize in regulatory affairs, pharmacovigilance, QA, QC, clinical development, and more.

We are committed to equal opportunity employment and welcome applications from all qualified candidates regardless of race, sex, disability, religion, sexual orientation, or age.