Regulatory Affair Specialist

1 ديسمبر، 2022

0 5 دقيقة واحدة

We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team! As a Regulatory Affairs Specialist, He/She will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations, starting from preparing the registration files for (Medicine, Supplements, Medical devices) until finalizing the registration with the concerned authority.

Responsibilities and Duties

Compile and maintain regulatory documentation databases or systems.
Coordinate with suppliers & distributors to prepare the required documents associated with the preparation of regulatory documents or submissions.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Communicate with regulatory agencies that Kepler deals with regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Preparing submissions of license variations and renewals to strict deadlines.
Developing and writing clear arguments and explanations for new product licenses and licenses renewals.
Providing strategic advice to senior management throughout the development of a new product.