Teamlead (m/f/d) Global Regulatory Affairs Pharmaceuticals Animal Health
vor 1 Monat
MSD Animal Health is a global, research-driven company that develops, manufactures and markets a wide range of biopharmaceutical products and services for veterinary medicine.
The company's strong research and scientific excellence has resulted in one of the most innovative portfolios in the industry, including products to prevent, treat and control disease in livestock and companion animals.
Schwabenheim an der Selz is one of MSD Animal Health's largest research sites outside the USA. Around 250 employees work here every day on the research and development of new veterinary medicines, in particular anti-infectives and antiparasitics - from research level to first administration.
As part of a succession plan, we are seeking to fill the following position as soon as possible:
Teamlead (m/f/d) Global Regulatory Affairs Pharmaceuticals Animal Health
Responsibilities:
- You will have overall responsibility for the management, organization and development of the Global Regulatory Affairs New Products Development Safety and Efficacy Pharma team
- You will be in charge of the disciplinary management of five employees at the site, who will report directly to you
- You will establish the development of submission strategies and timelines for assigned pharmaceutical products worldwide (except US) in accordance with global guidelines and regulations
- In your role, you will be responsible to manage the timely submission of marketing applications to the relevant authorities and the monitoring of all ongoing regulatory processes, focusing on safety and efficacy
- One of your tasks is to critically review safety and efficacy data in order to achieve the desired product profile and meet regulatory requirements
- As an expert within the team, you will assess and clarify any necessary post-approval changes and determine the actions required
- Working with your international and national colleagues, you will develop registration strategies for new and existing products in accordance with future regulatory requirements
- As an internal advisor to all cross-departmental teams at the site, you will support the assessment of veterinary regulatory enquiries and provide targeted and relevant global regulatory advice
- You will ensure reliable identification of potential regulatory issues and communicate these to senior management
- You are committed to achieving the company's goals and support the rapid and long-term marketing of products at home and abroad
- Your will be reporting directly to the Executive Director Global Regulatory Affairs of Safety, Efficacy and Licensing.
The requirements:
- Ideally you have studied veterinary medicine or have a comparable degree and have several years of expertise in the veterinary pharmaceutical industry
- Preferably, you have at least three years of experience in regulatory affairs. If you have extensive expertise in the preclinical or clinical veterinary pharmaceutical industry, you are equally welcome
- You have already managed employees for several years and can support your direct reports as required
- Your leadership style is characterized by developing and promoting people's professional and personal skills
- You demonstrate a high level of resilience in the face of a wide range of challenges and use your creative approach to find unusual solutions
- With a top-down view of complex processes, you are happy to take the helm in stormy situations
- Your personality is characterized by tact, diplomatic skills and scientific curiosity
- You are familiar with the unique characteristics of a multinational organization and are well acquainted with it
- Occasional willingness to travel, even for several days and intercontinentally
- You are fluent in English
The offer:
You have the unique opportunity to take on a key position in a well-structured market within an international organization and to significantly expand your area of expertise. You will be working in a research-based, future-oriented company with outstanding technical expertise, a broad product portfolio and a solid reputation as one of the market leaders in the industry, both worldwide and in Germany.
You can expect varied and challenging tasks. Your contribution is crucial to the success of the company, which is why you will also be involved in important decision-making processes as a manager.
The location near Mainz not only offers you a first-class pharmaceutical working environment, but also a lively city with a high quality of life, attractive infrastructure and an attractive surrounding area.
Our consultant Dr. Hendrik Schwarz and his team will be happy to make initial contact with you:
Please send your detailed application documents (CV, salary expectations and earliest possible starting date) by e-mail to -, quoting the reference number
www.hardenberg-
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