Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A leading global pharmaceutical company seeks a Senior Regulatory Affairs Manager focused on Emerging Markets. This remote role involves managing NDA strategies, collaborating with diverse teams, and ensuring compliant product launches across various regions. Ideal candidates will have extensive experience in regulatory affairs within the pharmaceutical industry.

Qualifications

• Experience in Regulatory Affairs within pharmaceutical sectors.
• Proven track record in NDA submissions and product launches.
• Strong understanding of regulatory requirements in emerging markets.

Responsibilities

• Manage NDA and line extension strategies for products in Emerging Markets.
• Develop regulatory strategies in collaboration with cross-functional teams.
• Act as the Regional Strategy lead, contributing to launch meetings.

Skills

Strategic Communication

Regulatory Strategy Development

Collaboration

Education

Bachelor's degree in Life Sciences or a related field

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 assigned products, working with partners, affiliates, supply chain, PV, commercial, and medical colleagues 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 RPT, providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is an American-headquartered employment business providing global staffing services with offices in Chicago and Central London. We operate compliantly in over 30 countries, supporting a network of 2,500+ contractors worldwide and offering 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 committed to equal opportunity employment and welcome applications from all qualified candidates regardless of race, sex, disability, religion, sexual orientation, or age.