Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A leading global pharmaceutical company is seeking a Senior Regulatory Affairs Manager for Emerging Markets. This role involves strategic management of NDA submissions and collaboration across various teams to optimize product launches. Ideal candidates will have strong regulatory knowledge and experience dealing with emerging markets.

Qualifications

• Experience in Managing NDA submissions and regulatory strategies.
• Knowledge of Emerging Markets regulations.
• Ability to work collaboratively with global and local teams.

Responsibilities

• Manage communication and implementation of NDA strategies.
• Develop regulatory strategies for assigned products.
• Serve as Regional Strategy lead within cross-functional forums.

Skills

Regulatory Strategy Development

Communication Management

Collaboration with Cross-functional Teams

Education

Degree in Life Sciences

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 local regulatory teams.
2. Develop and deliver regulatory strategies for assigned products in these markets. Work 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 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 over 2,500 active contractors and a strong permanent recruitment offering.

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/belief, sexual orientation, or age.