Our client, a global pharmaceutical company, in order to strengthen its structure, is seeking to recruit a
JOB Regulatory Affairs Advisor/Senior
PURPOSE OF JOB:
The RA Advisor/Senior supports and assists the Regulatory Affairs Manager to manage the activities related to pharma products (medical product, medical device, food supplement, cosmetics and PMC). He/She negotiates with the agencies and national authorities and prepares the whole set of permissions required in pharmaceutical by applying the relevant law/regulations.
The RA Advisor/Senior is responsible for the development of regulatory affairs strategies for submissions and maintenance of Marketing Authorizations/Registrations in EU and extra EU Health Authorities from development to post-market stage.
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to national and international commercial partners, advise on the submission strategy.
- Timely compile materials for new MA applications, renewals, variations (on preclinical, clinical, quality part of CTD dossier) of medicinal products and for food supplement, medical devices and cosmetics. Develop responses to questions or deficiency letters.
- Review Product Information (SmPC, PIL labeling) for compliance with regulatory requirements.
- Prepare and deliver regulatory submissions in line with defined CMC Regulatory plans. Review (including conducting regulatory impact assessments), coordinate and prepare CMC documentation for new and maintenance applications.
- Support company’s manufacturing sites and third parties.
- Obtain and maintaining regulatory approvals.
- Maintain regulatory files/database and chronologies in good order.
- Participate as required in project Launch Meetings, Review Meetings, Project Team meetings
- Participate in DD projects
- Participate in research of regulatory issues
- Spread regulatory information to Production, QA, QC. QP, Medical Affairs and QPPV departments and senior management as required.
SKILLS AND QUALIFICATIONS REQUIRED:
- Degree in scientific disciplines
- 7 to 10 years of experience in regulatory affairs in the pharmaceutical industry.
- Significant experience with CTD modules and applications (CMC experience is a plus)
- Very detail-oriented, well organized, strong capability to multi-tasks and driven to meet deadlines and program goals. Solid decision-making skills with strategic mindset.
- Ability to work well both independently and in a team environment.
- Excellent communications skills (verbal, written, listening, conveying messages)
- Solid computer skills,
- Fluent English required (oral & written)
La ricerca è rivolta a persone di entrambi i sessi ( L.903/77 ). Gli interessati sono pregati di inviare un dettagliato curriculum vitae in formato Word o PDF, con l’autorizzazione al trattamento dei dati personali (REG UE 679/2016), al seguente indirizzo: email@example.com , citando il riferimento RA_19