We are looking for a Senior Specialist Regulatory Affairs (m/w/d) in a temporary (2 years) position at our site in Schwabenheim.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
* Manage and prepare regulatory submissions with a focus on safety and efficacy, including responses to authority questions as required in each country, 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, provide regulatory timelines identify risks and propose mitigation strategies.
* Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.
* 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.
* Critically review key regulatory submissions and assessments and provide input to help achieve earliest regulatory approval and launch of products on schedule.
REQUIREMENTS:
* University degree in Veterinary Medicine, Medicine, Pharmacy or equivalent
* 3-5 years of regulatory and/or product development experience
* Proven ability to coordinate multiple projects and priorities and meeting critical deadlines
* Strong writing and oral communication skills
* Excellent people, communication and leadership skills
* Ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details
* Strong and effective communicator and negotiator with internal and external contacts
* Proficient in English
* High level of professionalism, experience in reviewing scientific information
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.