Head of Regulatory Operations
Vor 2 Tagen
We are seeking a highly skilled and experienced Head of Regulatory Operations to join our team at Merz Therapeutics. As a key member of our Global Regulatory Affairs Leadership Team, you will be responsible for leading and developing our Regulatory Operations team, ensuring the management of all activities around the technical creation, filing, and reporting of regulatory submissions.
Key Responsibilities- Lead the Regulatory Operations Team: Motivate and develop team members, creating an inspiring team environment with an open communication culture.
- Monitor and Optimize Data Entry and Regulatory Master Data Management: Manage data to ensure accurate regulatory reporting.
- Ensure Sufficient Planning and Execution of Electronic Submissions: Coordinate internal and external work packages, managing the budget to ensure all submissions are timely and within budget.
- Ensure IDMP/SPOR Requirements are Met: Ensure compliance with all relevant guidelines.
- Process and Quality Management: Take responsibility for continuous process improvements, generating ideas for further digitalization projects to support regulatory processes within the department, while ensuring high quality within the area of responsibility.
- University degree in pharmacy, chemistry, biology, biochemistry, or equivalent.
- At least 5 years of professional working experience in Regulatory Operations/Regulatory Affairs, ideally in a global environment.
- Leadership experience with a proven track record of successfully managing and inspiring teams.
- Knowledge in contract management and validation of computerized systems.
- Profound knowledge of common Regulatory Operations systems (RIMS, eDMS, eCTD Manager, eArchive), ticketing, and collaboration tools.
- Excellent communication skills in English.
- Proven ability to coordinate multiple projects/priorities and meeting critical milestones.
- High level of leadership skills and change management competencies.
- Strong and effective communicator with a team-oriented working style.
Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases, and other health conditions regain their quality of life. We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.
Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings. Our dedication and commitment to relentless research and development ensure that unmet patient needs are identified and appropriate treatments are provided.
Become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: "Better Outcomes for More Patients".
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