Team Lead New Products Development Associate Director Global Regulatory Affairs Animal Health in Schwabenheim bei MSD

We are looking to welcome a Team Lead (m/f/d) New Products Development Associate Director 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, bri