Regulatory Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
We provide pharmaceutical and life science companies with the strategic in-market and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.
We are looking for a REGULATORY AFFAIRS MANAGER to join our INTERNATIONAL TEAM.
In this role you will lead complex regulatory activities to support the development registration and lifecycle management of pharmaceutical products across EU and nonEU markets. Your experience will enable clients to build effective regulatory strategies and execute highquality submissions ensuring compliance with global regulations.
Key Responsibilities:
- Preparing reviewing and overseeing regulatory documentation for Marketing Authorization Applications (CTD Modules).
- Ensuring accuracy completeness and consistency of regulatory submissions in line with international guidelines and client requirements.
- Plan and manage regulatory procedures in the EU and beyond (e.g. MAA variations line extensions renewals).
- Contribute to the definition of global regulatory strategies supporting clients in selecting the optimal pathway based on product development stage.
- Support regulatory planning within clinical development and CMC projects.
Essential Requirements:
- Masters degree in Pharmaceutical Chemistry and Technology Pharmacy or related scientific fields.
- 58 years of experience in Regulatory Affairs within the pharmaceutical sector.
- Strong knowledge of EU and international regulatory frameworks (EMA FDA ICH) with experience managing multicountry projects.
- Excellent command of English both written and spoken.
- Strong project management mindset with the ability to coordinate multiple regulatory activities while ensuring quality and meeting deadlines.
Soft Skills:
- High level of autonomy and ownership.
- Strong analytical and advanced problemsolving skills.
- Clear communication and clientoriented attitude.
- Ability to make regulatory decisions based on a riskbenefit perspective.
Contract details:
- Type: Permanent
- Location: Pisa or Milan
- Hybrid work
Benefits:
- 10 meal voucher per working day
- Competitive corporate welfare plan
- Birthday leave
The selection respects Legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender sexual orientation age ethnicity and religious belief. This announcement is designed to respect diversity and inclusiveness.
