Regulatory Affairs Officer (Milan, IT, 20136)
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At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.
EG is a part of the STADA Group and we take care for italian people's health since 1998.
High production standards, ethical and sustainable development models, professional support to doctors and pharmacists and high training of our Field Forces are among the key factors of our success. These factors have led us to be a leading company in the Italian market of generic drugs and an active company in biosimilars, hospital-medicines and OTC.
For our offices in Milan we are looking for
Regulatory Affairs Officer
Milano | Italy (IT) | Full-time | Permanent
We are looking for a Regulatory Affairs Officer. The candidate will support regulatory activities related to the management and maintenance of marketing authorization dossiers, working closely with different company functions, external consultants, and the Pharmacovigilance team, providing support for activities related to the safety of medicinal and non-medicinal products.
Key Responsibilities
Regulatory review of artworks and management of packaging and leaflet updates in accordance with approved texts and applicable regulations.
Monitoring publications and updates issued by AIFA, EMA, and the Italian Official Gazetta (Gazzetta Ufficiale).
Supporting the management and maintenance of registration dossiers and the preparation of documentation required by the Authorities.
Managing regulatory activities related to non-pharmaceutical products and updating regulatory databases, electronic archives, and tracking systems.
Submission of advertising and scientific information materials and use of the main AIFA portals.
Requirements
Experience in Regulatory Affairs within the pharmaceutical industry, gained through the management of prescription medicines.
Experience with OTC and/or Consumer Healthcare (CHC) products will be considered a strong asset, demonstrating familiarity with different product categories and their respective regulatory requirements.
Previous exposure to Pharmacovigilance activities will be considered an advantage, as will a genuine willingness to collaborate with this function and progressively expand expertise in this area.
The ideal candidate is detail-oriented, well-organized, compliance-focused, able to work independently, and comfortable working in a cross-functional environment.
How We Take Care of Our People
Our Purpose, "Taking care of people's health as a trusted partner," guides our daily actions, including how we support our employees. We offer:
Wellbeing initiatives and mental health support for all employees and their families, including access to the Kyan Health app.
A continuous learning environment through our free e-learning platform and a language-learning platform available to all employees.
A Growth Culture and objectives aligned with our Purpose.
Are you looking for new challenges where you can make a difference for people's health? We are looking for candidates with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team.
We would be pleased get to know you. Please use our online portal to submit your application: jobs.stada.com
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Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 407 comparable Regulatory Affairs roles across 100 biopharma companies.
Salary context
116 of 407 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 407 comparable roles
+ 37 more countries
Seniority mix
332 of 407 peers have a known seniority level
Therapeutic area mix
38 of 407 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
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