Teamlead/associate Director

**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, Efficacy and Licensing pharma maintenance team and be responsible for developing product safety and efficacy regulatory lifecycle management submission strategies 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 lifecycle management 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
- Continuously build and share profound knowledge of safety and efficacy related regulations and guidelines, authority expectations, as well as current industry standards
- Disseminate relevant global regulatory guidance (e.g. EMA, 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 (preferred)
- 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**:

- Flextime (37.5 hours/week)
- Competitive salary package: 13 monthly salaries, plus target bonus
- Holiday allowance (1.200€ annually)
- 30 days holiday entitlement
- Attractive company pension scheme
- Corporate benefits
- On-the-job training and development opportunities

Our Animal Health division is a global leader in veterinary medicine and digital solutions dedicated to the health and well-being of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal health and well-being and supporting a safe food supply. Through our commitment to the Science of Healthier Animals®, we offer one of our industry’s most innovative portfolio of pharmaceuticals, vaccines and digital health management solutions including traceability and monitoring products that serve to prevent, treat, and control diseases across all major farm and companion animal species.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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**Employee Status**:
Regular

**Relocation**:
Domestic

**VISA Sponsorship**:
No

**Travel Requireme