Senior Regulatory Affairs Manager - Emerging Markets

JR United Kingdom; Chelmsford; Remote; GBP 70,000 - 90,000; Full time

Job summary

A leading global pharmaceutical company is seeking a Senior Regulatory Affairs Manager to oversee NDA strategies in Emerging Markets. This remote role requires collaboration with various stakeholders to develop and implement effective regulatory strategies. The ideal candidate will possess significant experience in regulatory affairs and a deep understanding of market requirements, ensuring optimal product launches and compliance.

Qualifications

• Extensive experience in regulatory affairs for pharmaceutical products.
• Strong understanding of emerging markets regulatory requirements.
• Proven ability to manage cross-functional teams and stakeholders.

Responsibilities

• Manage communication and implementation of NDA strategies across regions.
• Develop regulatory strategies in collaboration with multiple departments.
• Act as the Regional Strategy Lead in cross-functional meetings.

Skills

Regulatory Strategy Development

NDA Communication

Collaboration

Education

Relevant Degree in Life Sciences or Pharmacy

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 closely 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. Serve as a member of the Regional Product Team (RPT) as the Regional Strategy Lead, providing regional insights and contributing to cross-functional forums, including launch meetings.

About Planet Pharma:

Planet Pharma is an American-based employment business and agency providing global staffing services. Headquartered in Chicago with a regional office in Central London, we operate in over 30 countries with a network of more than 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 for 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/belief, sexual orientation, or age.