Teamlead/Associate Director (m/f/d) Global Regulatory Affairs Pharmaceuticals Animal Health

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are looking to welcome a Teamlead/Associate Director (m/f/d) Global Regulatory Affairs Animal Health to join our team in Schwabenheim, near Mainz, on a fulltime and permanent basis.

As the Teamlead/Associate Director (m/f/d) you will lead the Global Regulatory Affairs Safety and Efficacy pharma project team and be responsible for developing product safety, efficacy regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance.

Your main activities and responsibilities:

• Leading, motivating and developing team members in accordance with the company’s management principles
• Create an inspiring team environment with an open communication culture
• Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones
• Critically review all safety and efficacy data and documents to meet the desired product profile and regulatory requirements
• Manage and prepare regulatory submissions with a focus on safety and efficacy, including responses to authority questions as required in each country, in order to gain new and maintain existing product registrations. Ensuring timely submissions
• Develop regulatory strategies for new project developments and existing products with a view to future licensing requirements
• Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies
• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
• Disseminate relevant global regulatory guidance (e.g. FDA, EMA, EPA, CODEX, VICH guidelines) and policy to interdepartmental teams and provide specific product related guidance where relevant
• Develop and maintaining a strong technical knowledge in pharmaceutical product development (safety and efficacy)
• Identify and communicate potential regulatory issues to management, as needed

Your Profile:

• University degree in Veterinary Medicine
• 3-5 years’ direct experience in preclinical, clinical, regulatory affairs or other critical areas within the veterinary pharmaceutical industry
• Experienced in working with international contacts, able to be patient and open to other cultural habits
• Proven ability to coordinate multiple projects and priorities and meeting critical deadlines
• High level of professionalism and leadership skills (result-oriented, proactive, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details)
• Experience in reviewing scientific information and medical writing skills
• Strong and effective communicator and negotiator with internal and external stakeholders
• Proficient in English

Our Benefits:

• Trustbased working hours (37.5 hours/week) and an attractive company pension scheme
• Competitive salary package: 13 monthly salaries + holiday pay (EUR 1,200 annually) + target bonus achievement
• 30 days holiday entitlement
• Hybrid working model
• Internal further training and promotion opportunities
• International cooperation
• On-the-job training
• Contribution of own ideas to the process design
• Insights into the development of veterinary medicinal products
• Corporate benefits and free (e-) parking spaces
• Good company canteen and a company health management system

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Flex Time, Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

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