MSD Senior Specialist Animal Health Global Regulatory 

Germany, Rhineland-Palatinate 

617063343

Job Description

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

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.

REQUIREMENTS:

• University degree in Veterinary Medicine

• Proven ability to coordinate multiple tasks and meeting critical deadlines

• Strong written and oral communication skills

• Excellent people, communication and leadership skills

• Strong and effective communicator

• Proficient in English

• High level of professionalism, experience in reviewing scientific information, result-oriented, proactive, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details

Current Contingent Workers apply

Temporary (Fixed Term)

Not Indicated