We are looking for a highly skilled and experienced professional to join our team as a Regulatory Affairs specialist in the EU Submissions department. The ideal candidate will have a strong background in regulatory affairs, particularly in the pharmaceutical industry.

Roles and Responsibility

Prepare and submit regulatory documents to European authorities, including marketing authorizations and periodic safety update reports.
Develop and implement regulatory strategies to ensure compliance with EU regulations.
Collaborate with cross-functional teams, including legal, quality assurance, and product development.
Conduct thorough reviews of regulatory submissions to ensure accuracy and completeness.
Maintain up-to-date knowledge of changing regulatory requirements and guidelines.
Provide training and guidance to internal stakeholders on regulatory affairs matters.

Job Requirements

Strong knowledge of EU regulatory requirements, including MDR 2017/745 and GMP.
Experience in preparing and submitting regulatory documents to European authorities.
Excellent communication and project management skills.
Ability to work independently and collaboratively as part of a team.
Strong analytical and problem-solving skills.
Familiarity with regulatory software and systems is an advantage.

Regulatory Affairs Professional - EU Submissions

Job Description

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