Regulatory Affairs Specialist
2 settimane fa
Synergie Italia S.p.a. is seeking a highly skilled Regulatory Affairs Specialist to join our team in Rome, Italy.
Job Summary:We are looking for a talented Regulatory Affairs Specialist to support our Nutrition Division in ensuring compliance with regulatory requirements and guidelines. The successful candidate will be responsible for managing regulatory affairs, including registration, approval, and maintenance of products, as well as monitoring and implementing new regulations.
Key Responsibilities:- Support the development of regulatory strategies for new product registrations and reimbursement, taking into account the company's business strategy and regulatory requirements.
- Ensure the maintenance of products in line with regulatory requirements.
- Monitor and implement new regulations to support business growth and maintenance.
- Support the evaluation of the impact of upcoming regulations on products through industry associations.
- Register, approve, and include products in the National Register, and manage reimbursement, launch, and maintenance processes.
- Negotiate with regulatory authorities during the revision process to ensure registration and approval.
- Participate in NPI project teams and ensure timely completion of tasks and clear communication of regulatory risks and opportunities.
- Implement new regulations or orientations within legal terms.
- Approve labels, formulas, technical sheets, marketing and promotional materials, ensuring alignment with local regulations, codes of conduct, and SOPs.
- Provide technical and regulatory support to internal stakeholders.
- Work independently in a separate office from the Manager, collaborating with colleagues, including international ones.
- Engage in document/positioning work within industry associations for current and future regulations, evaluating and influencing the impact on activities for local sensitization.
- Evaluate and communicate the impact of regional regulations relevant to the local market.
- Indicate in reporting activities, products, budgets, productivity, contact levels (internal and external), or other measures of definition for which this work is responsible.
- Ensure all deadlines are met.
- Bachelor's degree or specialist degree in Sciences in one of the various branches of biology, chemistry, microbiology, medical technology, pharmacy, pharmacology, and equivalents.
- 2-3 years of experience in Regulatory Affairs, with expertise in Nutrition and General Food (food products, supplements, and nutritionals).
- Excellent English written and communication skills.
- Highly developed project management skills.
- Excellent problem-solving skills.
- Work for business objectives at a high level.
We offer an initial 6-month contract through our agency Synergie, with possible extensions. The working hours are full-time, from Monday to Friday, 9-18. The salary is € 2981.22 - RAL 41.7, corresponding to the CCNL Chimico Farmaceutico L. A3. The job is classified as QUADRO, with 14 monthly payments. We also offer a Ticket Restaurant Edenred of € 8 per day.
The job is located in Rome.
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