Senior Specialist Animal Health Global Regulatory Affairs Safety, Efficacy and Licensing (m/f/d)

We are recruiting for a Senior Specialist (m/w/d) Global Regulatory Affairs Safety, Efficacy and Licensing (Maintenance team) in a fulltime position at our site in Schwabenheim in a temporary position for 2 years.

The Senior Specialist Global Regulatory Affairs Safety, Efficacy and Licensing (Maintenance team) is responsible to develop post-approval regulatory strategies, timelines, and submissions for maintaining existing licenses in accordance with the regulations and guidelines.

The Senior Specialist Global Regulatory Affairs Safety, Efficacy & Licensing will work in the Maintenance team and has the following major responsibilities :

• Arrange documents, data, and all other items necessary for maintaining marketing authorizations. Ensure timely availability of the requested materials, in line with the licensing strategy.
• Collaboration in the preparation of reports and technical statements with internal and external experts on the respective assigned product classes (e.g., anti-infectives, anti-parasitics, anti-inflammatory drugs, hormones).
• Format, structure and send out submission packages to the local country organization and/or competent authorities and ensure timely follow up.
• Prepare and coordinate product literature (SPC, leaflet, label) updates according to the current regulations.
• Enter and manage data in the GRA data bases keeping them up to date.
• Critically review key regulatory submissions and assessments and provide input to maintain regulatory approval of products.
• Manage and prepare regulatory submissions, including responses to authority questions as required in each country, to maintain existing product registrations. Ensuring timely submissions.
• Assess post approval changes, provide regulatory filing strategies and timelines.
• Compilation of documentation for approval extensions.
• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.
• Develop and maintain a strong technical knowledge in pharmaceutical product development, the applicable legal regulations and ensure compliance with internal and external regulatory standards.
• Identify and communicate potential regulatory issues to management, as needed.
• Perform other tasks as requested by management.

Your Profile:

• Preferably a university degree in Veterinary Medicine
• 1-3 years of Animal Health Regulatory Affairs experience
• Proven ability to coordinate multiple tasks and meeting critical deadlines
• Strong written and oral communication skills
• Excellent people and collaboration skills
• Proficient in English
• High level of professionalism, experience in reviewing scientific information, result-oriented, proactive, ability to deal with multiple priorities, sound judgement and attentive to details

Benefits:

• Flexible working hours (37.5 hours/week) and an attractive company pension scheme
• Competitive salary package: 13 monthly salaries + holiday pay + target bonus
• 30 days holiday entitlement
• Hybrid working model (up to 50 % remote)
• Internal training and promotion opportunities
• International co-operations
• Training on the job
• Contributing your own ideas to the process design
• Insights into the development of veterinary medicinal products
• Corporate benefits and free (electric) car parking
• Good company canteen and a company health management program

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.