Senior Regulatory Consultant Lazio

Senior Regulatory Consultant
Roma
Lazio, Lazio

Duration - 1 year contract to start withWe're partnered with a growing innovative biotech who are leaders in providing biopharmaceutical solutions designed to drive customer success.

Their approach translates valuable clinical, medical, and commercial insights into impactful outcomes, addressing the challenges of today's market. With the successes and growth they have had over the years, they are now looking for a Senior Regulatory Consultant to join their team in Italy on a remote/hybrid basis to provide local regulatory and technical support for assigned products, including product development documents and regulatory agency submissions and implementing/managing project regulatory activities. Requirements: Degree, ideally in a science-related discipline, or equivalent experience in a science, regulatory, or medical writing field.

5+ years of relevant experience in the pharmaceutical or biotech industry, specifically within regulatory affairs.

Proven experience in assisting with Italian regulatory submissions, including Variations, Agency Question Responses, and MAAs, as well as handling negotiations with AIFA.

Exceptional communication and interpersonal skills, both written and verbal, with Italian as a native language.

Solid quality management skills.

Fluency in English, both spoken and written. Responsibilities:Assist in monitoring and staying updated on local regulatory requirements, proactively identifying, assessing, and communicating any changes to the local affiliate in a timely manner.

Help respond to inquiries from other departments, such as medical and supply chain, regarding matters like compassionate use, early access programs, local labelling exemptions, CTA requirements, and more.

Support the proper implementation of national regulations for MAAs and any subsequent variations related to centrally approved products.

Review and approve translations for artworks and product information.

Evaluate both promotional and non-promotional materials to ensure compliance with local requirements and handle submissions or approval processes as necessary.

Contribute as a local regulatory expert within multidisciplinary teams, which may include clinical and technical experts, to help develop products throughout their entire lifecycle.

Serve as the local regulatory subject matter expert for Italy, assisting team members in resolving day-to-day issues and offering solutions to project challenges.

Ensure adherence to local regulatory standards as well as company policies and procedures. About Planet Pharma:Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London.

We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field.

Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery.

We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency.

We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.