Role Purpose
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 Job Requirements
- 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 < 18” away from face for extended period of time – up to four (4) hours at a time.
- 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.
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