Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A global pharmaceutical company is seeking a Senior Regulatory Affairs Manager to oversee NDA strategies for Emerging Markets. This remote role requires collaboration with various teams to deliver effective regulatory strategies, impacting key markets including MEA, CIS, and CEE. Ideal candidates will possess strong communication skills and experience in regulatory affairs.

Qualifications

• Experience managing NDA strategies in Emerging Markets.
• Ability to collaborate with global regulatory teams.
• Strong understanding of regulatory requirements across regions.

Responsibilities

• Manage communication and development of NDA strategies for Emerging Markets.
• Collaborate with cross-functional teams to ensure timely delivery of regulatory strategies.
• Provide regional insights as the Regional Strategy lead.

Skills

Regulatory Strategy Development

Communication

Collaboration

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 and affiliates, supply chain, PV, commercial, and medical colleagues to determine optimal NDA filing and launch strategies. Ensure timely delivery of strategies in partnership with CRO.
3. Participate as a member of the RPT as Regional Strategy lead, providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is a global staffing services provider headquartered in Chicago, with an EMEA regional office in Central London. Recognized by FORBES as the 17th best professional staffing firm, we operate in over 30 countries with a network of 2500+ active contractors. We specialize in Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions, Clinical Development, and Medical Affairs, among others.

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.