Bennett Pharmaceutical Industry is a 100% Greek company, which is active in the whole spectrum of the pharmaceutical industry.
We produce high quality generic and original formulations, investing in Research & Development, Innovation, and new technologies. For this reason, Bennett has established itself as the fastest growing company in the pharmaceutical market.
The continuous modernization of our infrastructure and the ongoing training of our personnel aim to provide a substantial service to those who need our products, ensuring a high quality of life.
We are looking for a Regulatory Affairs Manager based in the Company’s headquarters in Kifisia.
Role Description:
- Handling of Marketing Authorization new applications (MAA), variations, and renewal procedures in EU/Non-EU through MRP, DCP, CP, NP
- Communication with Authorities and any third party (e.g. client, partner, ASMF holder) for successful registration of the projects
- Dossier life-cycle management/Appropriate archiving
- Preparation of Module 1 documentation for all MA applications
- Review of Quality Part of the dossier (Module 3)
- Review batch manufacturing documents, on-going stability results, process validation protocols and reports needed for dossier compilation as well as for identifying any regulatory impact for marketed products
- CMC knowledge of Module 2-3 of a dossier intended for submission is considered an asset.
- Use of eCTD manager for regulatory submissions
- Compilation of scientific responses to deficiencies (DCP, CP and national) raised by regulatory agencies worldwide
- Good knowledge of EU regulatory legislation
- Monitor and review EMA and ICH guidelines with regards to quality aspects of a pharmaceutical product
- Managing Life Cycle Management RA activities and translation of technical documentation (i.e. technical documentation, SPC, PIL and labeling, securing compliance with registration requirements across centralized MRP and national procedures.
- Employee training in local regulations
- Oversaw all regulatory aspects ensuring compliance with national and MR/DC procedures
- Translation of technical documentation such as technical files, securing compliance with registration requirements across centralized, MRP and national procedures.
- Providing support in the review of promotional materials and press releases, working closely with Medical and Business.
- Responsibility of the company compliance with corporate guidelines regarding liability to Health Authorities and external partners.
Qualifications:
- Degree holder in Life sciences: Pharmacy, Chemistry, or similar scientific disciplines
- Master’s/PhD is considered an asset.
- 5+ years of experience in regulatory affairs with a focus on submissions
- Oral and written communication in English in proficient level
- Team working spirit.
- Ability to manage varied tasks with attention to detail.
- Critical thinking, problem-solving and decision-making skills
- Organization and time management skills
- Strong interpersonal and communication skills.
- Advanced Computer skills (word, excel, ppt etc)
Company offers:
- Competitive remuneration package.
- Private medical health insurance.
- Friendly and challenging working environment.
- Career development and progression opportunities
We promote initiative, creativity, and imagination, instilling our vision in our employees so that they work towards its realization by making the most of their own skills and abilities!