Regulatory Affairs Consultant – EMEA Strategy – Zug
NonStop Consulting
We are seeking a Associate Detector/ Director level Regulatory Affairs Consultant to join our client’s team. In this role, you will lead their EMEA submission and Marketing Authorization Application (MAA) strategy, ensuring their products meet the regulatory requirements across the region.
What makes this position challenging is that you will be part of the first hiring team for Europe as this company has successfully completed a M&A. Here you will design and implement regulatory plans for the EMEA business unit.
The TA focus area for this company is mainly OTC/ Consumer Health; as such, it will be important that you wont shy away from being hands on and working in a fast paced environment.
This is a long-term contract for minimim 12 months
Key Responsibilities:
- Develop and execute regulatory strategies for EMEA submissions and MAAs.
- Lead the preparation, review, and submission of regulatory documentation in compliance with regional requirements.
- Liaise with health authorities and regulatory agencies to facilitate approvals and resolve queries.
- Provide strategic regulatory advice to cross-functional teams, including R&D, clinical, and commercial departments.
- Monitor changes in the regulatory environment and assess their impact on company projects and products.
- Manage timelines and ensure timely submissions to avoid delays in product launches.
- Contribute to the development and implementation of regulatory policies and procedures.
Qualifications:
- Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
- Extensive experience in regulatory affairs within the pharmaceutical industry.
- Proven track record of successful EMEA submissions and MAAs.
- Strong understanding of regulatory requirements and guidelines in the EMEA region.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team, with strong leadership capabilities.
- Detail-oriented with strong organizational and project management skill
