Senior Regulatory Affairs Manager - Emerging Markets

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

Job summary

Une entreprise pharmaceutique de premier plan recherche un Senior Regulatory Affairs Manager pour gérer les stratégies d'enregistrement dans divers marchés émergents. Ce poste à distance implique des responsabilités significatives en collaboration avec des équipes mondiales et régionales. Une expertise en réglementation et une forte capacité à mener des stratégies complexes sont requises.

Qualifications

• Expérience avérée en affaires réglementaires dans les marchés émergents.
• Compréhension des stratégies de dépôt NDA.
• Capacité à travailler avec des équipes internationales.

Responsibilities

• Gérer la communication et le développement des stratégies NDA pour les produits assignés.
• Développer des stratégies réglementaires en collaboration avec divers partenaires.
• Participer aux forums inter-fonctionnels et fournir des informations régionales.

Skills

Communication

Strategy Development

Regulatory Knowledge

Education

Master's in a relevant field

Job description

Role: Senior Regulatory Affairs Manager - Emerging Markets

Location:

Remote, UK

Company:

Global Pharmaceutical

Contract Duration:

12 months, full-time

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), working closely with global, regional, and in-country teams.
2. Develop and deliver regulatory strategies for assigned products, collaborating 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. Participate as a Regional Strategy lead in the RPT for assigned products, 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 an EMEA regional office in Central London. We operate in over 30 countries, supporting over 2,500 active contractors worldwide, and offer specialized recruitment in areas including Regulatory Affairs, Pharmacovigilance, QA, QC, Clinical Development, and Medical Affairs.

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.