Regulatory affairs specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fqllr

Job Purpose We are looking for a Regulatory Affairs Specialist to join the International Corporate Regulatory Affairs team, responsible for managing regulatory activities for SPC medicinal products for human use.

Responsibilities include obtaining and maintaining marketing authorizations in the European Union (through CP/MRP/DCP) as well as supporting regulatory activities in various non‐EU regions, including Africa, Asia Pacific, CENAM, CSI, LATAM, MENA.

Key Responsibilities Preparation, review and submission of regulatory documentation to Health Authorities. Management of regulatory data and documentation within relevant electronic systems, in support of new marketing authorization applications. Line extension. Renewal of marketing authorizations.

Variations

Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation. Marketing authorization transfers. Notification of start and end of marketing.

Requests for sunset clause exemptions. Review and approval of printed materials (artworks and mock‐ups). Request for Notified Body opinions. Define regulatory activity plans and related costs. Collaborate with cross‐functional teams to define and manage timelines for the preparation of regulatory submissions.

Contribute to the management of core dossiers, including gap analysis activities, to support registrations across multiple international markets, in collaboration with relevant departments. Coordinate with the group's affiliates, licensees and consultancy companies.



Maintain relations with regulatory authorities.

Monitor legislation in force and assure regulatory compliance. Provide regulatory assessment for new business opportunities.

Required Education Scientific degree. Master in Regulatory Affairs (preferred).

Required Skills and Experience More than 5 years of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies.

Experience with the EU Centralised and Decentralised Procedures.

Background in OTC product development and lifecycle management. High level of autonomy in managing assigned activities.

Technical Competencies

In-depth knowledge of pharmaceutical legislation for medicinal products for human use and medical devices.

Experience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, e CTD platform).

Required

Behaviours and Competencies Positive and proactive mindset, with a solution‐oriented approach. Strong communication and collaborative skills, team‐player attitude. Effective time management and organisational skills. Flexibility and adaptability in a dynamic environment. Strong work ethic.

Required Languages

Fluent in English. We are proud to be an equal‐opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fqllr