Regulatory Affairs Junior Officer/Trainee
Regulatory affairs Junior Officers/Trainees ensure and provide support for the appropriate registering, licensing, marketing, and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products. Combination of scientific knowledge, legal and business issues, ensure products, which are developed, manufactured, or distributed by a wide range of companies, meeting the required legislation.
Experience required:
At least 1 year of experience in a similar work position for junior officers, no experience required for trainees.
Duties required:
- Audit and update of regulatory correspondence files/logs, and submission archives
- Assist on product registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralised, Decentralised and Mutual Recognition Procedures).
- Ensure regulations compliance (National and European regulations) for all Qualitec and other companies’ products.
- eCTD compilation.
- Collect and evaluate scientific data.
- Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs.
- Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working.
- Advise clients and manufacturers on regulatory requirements.
- Work with specialist computer software and resources (eCTDmanager, Lorenz eValidator, RAEFAR, GESFARMA, etc).
- Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity.
Education and skills required:
- B.Sc. degree in life science (Chemistry, Biology, Pharmacy, etc).
- Master or related course in Regulatory Affairs.
- English level: High.