Menarini Hellas, an international pharmaceutical company seeks to recruit a dynamic professional for the Regulatory Affairs Dpt. The candidate will be responsible for contributing to Regulatory & Quality activities performed on the RA department including pre and post licensing activities and product quality issues
The Main Responsibilities Include
- Prepare, maintain and update local product registration and regulatory compliance files of OTC products (i.e food supplements, medical devices, herbal medicines, biocides)
- Review of regulatory documentation for pharmaceutical products in line with assigned timelines
- Responsible for the preparation and modification of the packaging materials of products of the company according to the latest approved registration data.
- Preparing the translation of regulatory documents (product information, marketing authorizations) of products of the company.
- Checking of promotional materials of products of the company ensuring their compliance to approved registration data.
- Product complaints management (recording, assessing, follow up actions, sample tracking within specific timelines, deviations management).
- Knowledge and ability to apply regulatory guidelines and company SOPs
- Acting as a contact point with clients, consumers, healthcare professionals regarding product defects.
- Support to any other Regulatory Affairs & Quality activities.
Skills and Qualifications
- University Degree in Pharmacy, Biology, Chemistry or related scientific discipline
- Minimum 2 years of experience in Quality departments
- Fluency in English / Fully computer literate
- Strong knowledge of all regulation, legislation, policies and procedures related to RA activities and Quality operations
- High level of confidentiality and integrity
- Independent, confident, self-driven, pro-active, with “can do attitude”, detail-oriented
- Team player
The company offers a competitive remuneration package and career prospects.
If you meet the above qualifications and believe that you can respond dynamically to the requirements of the position, please send us curriculum vitae by entering accordingly the code position RA_2024 at firstname.lastname@example.org. All applications will be treated as confidential.