Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A leading global pharmaceutical company is seeking a Senior Regulatory Affairs Manager to oversee regulatory strategies in Emerging Markets. This remote position requires collaboration with various teams to ensure timely delivery of NDA filings and launching strategies. Candidates with extensive experience in regulatory affairs and strong communication skills are encouraged to apply.

Qualifications

• Extensive experience in Regulatory Affairs, particularly in Emerging Markets.
• Ability to manage NDA strategies.
• Strong communication skills and cross-functional teamwork.

Responsibilities

• Manage NDA and line extension strategies for Emerging Markets.
• Develop regulatory strategies with multiple teams for optimal filing.
• Contribute regional insights as part of the RPT.

Skills

Regulatory Strategy Development

Cross-functional Collaboration

Communication

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), working closely with global, regional, and in-country regulatory teams.
2. Develop and deliver regulatory strategies for assigned products in these markets, 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 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 an American-owned employment business providing global staffing services, headquartered in Chicago with an EMEA 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 for our commitment to excellence. Our expertise spans Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions, Clinical Development, Quality, Biostatistics, and Medical Affairs/Writing.

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