Senior Regulatory Affairs Officer 591

ProductLife Group is looking for a Senior Regulatory Affairs Officer to work for one of our clients in the Pharmaceutical industry.

About us

Responsibilities

Create regulatory strategies for new products and new markets.
Manage the regulatory aspects and licensing of Orphan Drugs within the Intercontinental countries.
Obtain new Marketing Authorisations in the Intercontinental markets for designated products/ and designated region and manage the documentation generation process, submission, assessment, approval and product launch regulatory steps.
Maintain existing licences (commitments, variations, renewals).
Obtain/ generate/ write appropriate documentation necessary to satisfy health authority requirements in the relevant countries
Prepare and submit any type of application (Clinical Trial Application, Marketing Authorization Application, variation application, Orphan Drug application, renewal application)
Communicate directly with the relevant departments, distributors and local partners on the generation of any regulatory documents.
Communicate directly with the MHRA (country of origin) and other health authorities seeking advice, guidance or clarification of legal issues or submission processes in conjunction with line manager.
Generate regulatory dossiers in eCTD format.
Actively and accurately maintain RA data bases, documentation and procedures to ensure regulatory compliance of products released to market.
Continuously identify and make proposals for minor and major improvements related to work place, processes and/or systems