Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: International Regulatory Affairs Specialist ID: 809 Date of Posting: Jun 28, 2024 Job Family: Regulatory Affairs Job Type: Direct Employee Location: Milano, IT Territory: Shift: 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 force, listed on the Italian stock exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, 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 We are looking for a Regulatory Affairs Specialist to join the international team of Corporate Regulatory Affairs for the management of regulatory activities for for medicinal products for human use, such as obtaining and maintaining marketing authorizations through the implementation of the procedures in use in the European Union (CP, MRP / DCP, CP) as well as in various non-EU geographical areas (Africa, Asia Pacific, CENAM, CSI, LATAM, MENA).
Key Responsibilities The candidate will be responsible for the preparation, review, submission to regulatory authorities of all relevant documentation and management in the identified electronic systems of the data and documentation to support: new Marketing Authorization Applications line-extension, renewal of marketing authorizations variations of type IA, IB, II (grouping and worksharing procedure) or equivalent in accordance with national legislation marketing authorization transfer notification of start/end of marketing requests for Sunset Clause exemption review and approval of printed material (artworks and mock-ups) Request for Notified Body Opinion Based on the products assigned, the Regulatory Affairs Specialist will also: Define the plan of the activities and related costs Cooperate with cross-functional teams to determine and manage timelines for the preparation of regulatory filings Participate in the management of core dossiers, including gap-analysis activities, to support the registration in different territories worldwide, collaborating with the 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 the regulatory compliance Provide regulatory assessment for new business opportunities Required Education Scientific Degree Master in Regulatory Affairs (preferred) Required Skills and Experience 4-5 years experience within regulatory affairs of multinational pharmaceutical firms (ideally in "parent companies") or international regulatory consulting companies High level of autonomy on the assigned activities In-depth knowledge of pharmaceutical legislation for medicinal products for human use and medical device 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 Communicative, collaborative and cooperative attitude (Team player) Efficient time management Flexibility Strong work ethic Required Languages 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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