Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A global pharmaceutical company seeks a Senior Regulatory Affairs Manager to oversee strategies for emerging markets, including MEA and CEE. This remote position requires strong regulatory expertise, especially in NDA filings and collaboration with cross-functional teams. The ideal candidate will possess significant experience in the regulatory domain and will play a vital role in ensuring timely product launches.

Qualifications

• Experience in Regulatory Affairs with focus on Emerging Markets.
• Proven track record in managing NDA filing and strategies.
• Ability to collaborate across global, regional, and local teams.

Responsibilities

• Manage NDA and line extension strategies for products in MEA, TCR, and CEE.
• Collaborate with various teams for optimal filing and launch strategies.
• Serve as Regional Strategy Lead within the Regulatory Product Team.

Skills

Regulatory Affairs

NDA Strategies

Emerging Markets Experience

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 is 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, working closely with global, regional, and local regulatory teams.
2. Develop and deliver regulatory strategies for assigned products in these regions, 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. Serve as Regional Strategy Lead for assigned products within the Regulatory Product Team (RPT), providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is an American-owned employment business providing global staffing services, headquartered in Chicago with a regional office in Central London. We operate in over 30 countries with a network of 2,500+ active contractors and offer specialized recruitment in areas including Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions, Clinical Development, and Medical Affairs.

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