Regulatory Affairegulatory Affairs Associate - Fix-Term Contractrs Associate - Temporary

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RegulatoryAffaiRegulatoryAffairs Associate - Fix-term contractrs Associate - Temporary
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ID: ****
Date of Posting: Jun 25, ****
Business Area: Regulatory Affairs
Job Type: Direct Employee
Territory:
Full-Time or Tempo parziale: Full Time
Seniority: Entry level
Job Purpose
We are looking for a Regulatory Affairs Associate - Fixed-term contract 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
New Marketing Authorisation 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)
Based on the products assigned, the Regulatory Affairs Associate will also:
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 the Regulatory Authorities
Monitor the 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
At least 6 months/1 year of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies
In-depth knowledge of pharmaceutical legislation for medicinal products for human use
Experience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, eCTD 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
Salary
Gross Annual Salary starting from: 36,000 €
Please note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts.
Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity.
At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of your total rewards package will be shared and discussed with you during the recruiting process.
Equal Opportunity Statement
At Recordati we believe in people!
Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion.
We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer.
xysqume 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.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ayytt