Vice President Regulatory Affairs

Medella Life; Remote; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

A growing pharmaceutical organization is seeking a Vice President of Regulatory Affairs to oversee regulatory strategies across Germany and Europe. The ideal candidate will have over 15 years of experience in pharmaceutical regulatory affairs, including significant senior leadership. Responsibilities include defining regulatory strategies, leading submissions, and managing a high-performing team. This remote role requires fluency in English and a strong understanding of German regulatory frameworks.

Qualifikationen

• 15+ years of experience in pharmaceutical Regulatory Affairs with significant senior leadership responsibility.
• Strong experience with German regulatory authorities (BfArM, PEI) and European regulatory frameworks (EMA).
• Proven track record of leading successful regulatory submissions and approvals.

Aufgaben

• Define and implement regulatory strategies for clinical programs and product registrations.
• Lead regulatory submissions and approvals, including CTA, MAA, and renewals.
• Build, mentor, and lead a high-performing Regulatory Affairs team.

Kenntnisse

Regulatory strategy

Leadership

Stakeholder management

Cross-border team management

Clinical development

Fluent English

German (Preferred)

Ausbildung

PhD or MD in Life Sciences, Pharmacy, or Medicine

Jobbeschreibung

Role Overview

We are representing our client in the search for a Vice President, Regulatory Affairs, based in Germany (remote). This role provides executive-level responsibility for leading the regulatory function and shaping regulatory strategy across Germany and Europe within a growing pharmaceutical organisation.

You will define and execute regulatory strategies covering clinical development, marketing authorisations, and lifecycle management of pharmaceutical products. Acting as the primary interface with regulatory authorities. You will ensure regulatory considerations are embedded across R&D, Clinical Development, Quality, and Commercial functions to support efficient development timelines and successful product launches.

Key Responsibilities

These responsibilities cover strategy, operations, leadership, external representation, and the candidate profile.

Regulatory Strategy & Leadership

• Define and implement regulatory strategies for clinical programmes and product registrations in Germany and the EU
• Advise the Executive Board on regulatory risks, opportunities, and compliance considerations
• Align regulatory strategy with corporate objectives to maximise patient access and commercial outcomes

Regulatory Operations

• Lead regulatory submissions and approvals, including CTA, MAA, variations, renewals, and post-approval commitments
• Manage interactions with BfArM, PEI, EMA, and other relevant health authorities to facilitate approvals and resolve regulatory issues
• Ensure compliance across the full product lifecycle, including post-marketing obligations and safety commitments

Team Leadership & Development

• Build, mentor, and lead a high-performing Regulatory Affairs team across clinical, CMC, and lifecycle activities
• Drive cross-functional collaboration to ensure regulatory requirements inform early-stage development and commercialisation planning

External Representation

• Represent the company in discussions with regulatory authorities, industry associations, and professional forums
• Establish strategic relationships to strengthen the company’s regulatory credibility and visibility in Germany and Europe

Candidate Profile

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline; PhD or MD strongly preferred
• 15+ years’ experience in pharmaceutical Regulatory Affairs, including significant senior leadership responsibility
• Strong experience with German regulatory authorities (BfArM, PEI) and European regulatory frameworks (EMA)
• Proven track record of leading successful regulatory submissions and approvals across multiple therapeutic areas
• Solid understanding of clinical development, CMC, and product lifecycle management
• Strong leadership, strategic thinking, and stakeholder management skills
• Experience leading remote and cross-border teams
• Languages: Fluent English (Required) & German (Preferred)