Urgent: Regulatory Affairs Manager International Sales

3 days ago

Cork, Ireland Recordati Full time

Regulatory Affairs Manager International Sales

ID: 1128

Date of Posting: Dec 12, 2024

Business Area: Regulatory Affairs

Job Type: Direct Employee

Location: Cork, IE

Territory:

Full-Time or Part-Time: Full Time

Seniority: Mid-senior

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.

Job Purpose

In coordination with area managers and HQ Regulatory, defines international regulatory priorities through timely coordination of regulatory activities between Recordati internal stakeholders and third parties in the countries to support the International Sales business.

Key Responsibilities

- Act as Regulatory’s point of contact for the area managers
- In alignment with HQ regulatory team, act as point of contact with local partners to define submission strategies and required documentation
- Cooperate with cross-functional teams to determine and manage timelines for the preparation of regulatory filings
- Contributes to business cases (and later contract editing) related to International Pharma Sales (SALINT)’s corporate products, in particular by agreeing on the action plan with HQ regulatory team
- Cooperates to M&A and in-licensing assessments for SALINT’s corporate products
- Collaborate with HQ regulatory team on the lifecycle management of Marketing Authorizations related to SALINT
- Ensure maintenance and update of the regulatory status of registered products (e.g. MAH status, MAT status related to SALINT activities…) using defined archiving systems
- Manage appropriate archiving of official approval documents and correspondence from the Regulatory Authorities for SALINT products/partnerships
- Responsible for creating and maintaining a yearly roadmap to ensure prioritization of regulatory activities for International.
- Provide all needed information concerning budget and forecast for SALINT products and activities
- Concerning SALINT corporate products, provide on time information on activities and planning

Required Education

Relevant degree in a subject such as chemistry, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science (regulatory certifications would be a plus)

Required Skills and Experience

- At least 4 years of regulatory experience in multinational pharmaceutical environment.
- Previous experience in international Regulatory Affairs is mandatory.
- A general understanding of pharmaceutical regulations applicable in Europe, Latin America, Asia, Pacific, Middle East
- Knowledge of the CTD dossier and product information, and related guidelines

Required Behaviours and Competencies

- Project management
- Communication skills and in particular ability to work with different cultures
- Management by influence, i.e. ability to promote International Sales Regulatory projects within the organisation

Required Languages

Very strong command of English (Italian a plus)

Travel required in %

30%

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. 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.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

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