Senior Specialist Global Regulatory Affairs (m/w/d)

Our Regulatory Affairs team bring 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.
We are looking for a Senior Specialist Global Regulatory Affairs Safety, Efficacy & Licensing (m/f/d) to join our team in Schwabenheim, Germany. This position will primarily support the implementation of the new veterinary legislation ((EU) 2019/06) and will be a full-time contract limited to 3 years.
RESPONSIBILITIES:

• Prepare and coordinate product information updates according to the required new format (QRD9 and following), assist with the regulatory procedures in the EU countries
• Prepare and coordinate SPC- harmonization in cooperation with Product Managers, support the respective regulatory procedures in the EU
• Prepare and coordinate product information updates for products with regards to the dose adjustment and the latest SPC guideline
• Build and share knowledge concerning the implementation processes, related regulatory procedures and authority expectations
• Identify and communicate potential regulatory issues to management, as needed
• Support post-approval regulatory strategies, timelines, and submissions for maintaining existing licenses in accordance with the regulations and guidelines

YOUR PROFILE:

• Preferably a university degree in Veterinary Medicine
• Preferably experience in a safety and efficacy related regulatory position (veterinary)
• High level of professionalism, experience in reviewing scientific information, result-oriented, proactive, ability to deal with multiple priorities, sound judgement and attentive to details
• Strong written and oral communication skills
• Excellent people and collaboration skills
• Proficient in English
• Proficient in MS Office applications

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.
People with severe disabilities and their equivalents will be given preference if they are equally qualified.
Required Skills:
Adaptability, Adaptability, Audits Compliance, Collaborative Communications, Communication, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, EU Regulations, Global Communications, Management Process, Medical Communications, Oral Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Product Data Management Systems, Product Lifecycle, Product Management, Program Implementation, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Issues {+ 4 more}
Preferred Skills: