Senior Manager, Regulatory Affairs

The Senior Manager, Regulatory Affairs, EU & ROW will manage assigned regulatory affairs activities through preclinical and clinical development.

Key Responsibilities

• Ensures timely planning, coordination, submission and approval of clinical trial applications, PIPs, scientific advice briefing books, marketing applications, etc.
• Interact with regulatory agencies and develop and maintain strong relationships with competent authorities both remotely and face to face.
• Responsible for submitting high quality regulatory documents required to obtain successful outcomes.
• Manage activities required to meet regulatory requirements, global guidelines and other required procedures within assigned projects.
• Own and manage document development and submission such as IMPDs, scientific advice briefing books etc.
• Act as EU/ROW regulatory representative on clinical study teams and translate regulatory requirements for project team members.
• File and track of regulatory activities for assigned projects, and maintain internal processes to ensure compliance.
• Provide support to cross functional project team members on Regulatory matters impacting the project.
• Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines.
• Bachelor's degree in Regulatory Affairs, Life Sciences, or a related discipline required, Master's degree preferred.
• 5+ years of experience in regulatory affairs within pharmaceuticals, biotechnology, or medical devices.
• Minimum 3 years of managerial or team lead experience.
• Demonstrated success managing regulatory submissions and product approvals.

Preferred Skills & Experience

• Deep knowledge of U.S., EU, and international regulatory frameworks (FDA, EMA, ISO, MDD/MDR, GxP).
• Strong project management and organizational skills with ability to drive complex submission timelines.
• Excellent written and verbal communication; strong ability to negotiate with regulatory agencies.
• Analytical problem solving skills with proven ability to assess regulatory risks and impact.
• Cross functional leadership and influence across diverse teams.

Essential Physical Requirements

• Ability to view video display terminal images
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time - up to four (4) hours at a time.
• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to lift, tug, pull up to fifteen (15) pounds.
• To be considered for this position, you must apply and meet the requirements of this opportunity.

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as negotiated to meet the on going needs of the organization.

United Kingdom

12 Hammersmith Grove
London, W6 7AP

Germany

Robert Rossle Str. 10
D-13125 Berlin