Regulatory Affairs Expert Wanted
We are seeking a seasoned Regulatory Affairs expert to join our team.
About the Role
This role will be responsible for all aspects of regulatory affairs, including existing licensed products and those under development. The successful candidate will report directly to the Regulatory Affairs Manager and collaborate with cross-functional teams.
Main Responsibilities
* Prepare and maintain high-quality dossiers (marketing authorisation applications/response to health authority questions/post-approval submissions).
* Submit CPP/manufacturing authorisation requests to relevant authorities.
* Review data intended for submission and advise on any deficiencies or issues.
* Ensure timely submissions for all quality/safety related changes for assigned projects.
* Prepare and submit translated texts to EU/Non-EU countries.
* Update databases and systems for all products in-line with current SOPs.
* Liaise with third parties to establish effective communication and relationships to progress regulatory activities.
Requirements and Qualifications
* Masters/Bachelor's degree or equivalent in Science/Technology/Pharmacy.
* Minimum 7 years of experience in regulatory affairs.
* Ability to understand health authority expectations for pharmaceuticals in EU/US/ROW regions.
* Strong organisation skills, time management skills, and attention to detail.
* Excellent critical thinking and problem-solving abilities.
* Strong interpersonal and communication skills.
* Experience dealing with multiple stakeholders, both internal and external.