Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

A leading pharmaceutical company is seeking a Senior Regulatory Affairs Manager to oversee NDA strategies in Emerging Markets. This remote role entails working closely with various teams to ensure regulatory compliance and timely product launch. Candidates should possess strong regulatory expertise and experience in the specified regions.

Qualifications

• Experience in Emerging Markets including MEA, TCR, and CEE.
• Proven track record in managing NDA and regulatory strategies.
• Strong collaboration skills with cross-functional teams.

Responsibilities

• Manage communication and implementation of NDA strategies for assigned products.
• Develop regulatory strategies collaborating with partners and local teams.
• Contribute as Regional Strategy lead in cross-functional forums.

Skills

Regulatory Affairs

Strategic Communication

Project Management

Education

Relevant Bachelor's or Master's degree

Job description

Role: Senior Regulatory Affairs Manager - Emerging Markets

Location:

Remote, UK

Company:

Global Pharmaceutical

Job Description:

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 a 12-month full-time contract.

Responsibilities:

1. Manage communication, development, and implementation of NDA and major line extension strategies for assigned products in the specified regions, collaborating with global, regional, and local regulatory teams.
2. Develop and deliver regulatory strategies for assigned products, working 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 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 US-based employment agency with headquarters in Chicago and an EMEA regional office in Central London. We operate in over 30 countries with a network of 2,500+ contractors and specialize in staffing services across various functions including Regulatory Affairs, Pharmacovigilance, QA, QC, Clinical Development, and Medical Affairs. Recognized by FORBES as the 17th best professional staffing firm, we are committed to diversity and equal opportunity employment.