JOBILY AI SUMMARY
What you'll do
- Coordinate with internal departments and external partners to gather data for regulatory submissions
- Compile and review documentation in line with NTA and ICH guidelines for pharmaceutical dossier submissions
- Prepare responses to health authority queries and manage variation filings
- Support lifecycle management of marketing authorizations including renewals and post-approval changes
- Ensure timely submission and tracking of regulatory projects to meet deadlines
- Maintain compliance of registered and marketed products with current regulatory requirements
Key requirements
- 2+ years' experience
- Regulatory Affairs and CMC knowledge
- EU regulatory framework and ICH guidelines understanding
- GMP and GLP standards familiarity
- Regulatory dossier preparation and documentation review skills
- Fluency in English
- MS Office proficiency
- Organizational skills and time management
- Communication and interpersonal skills
- Chemistry / Chemical Engineering / Biology / Pharmaceutical Studies
About the job
We are looking for a detail -οriented and proactive Regulatory Affairs & CMC Officer to join our team. In this role, you will play a key part in ensuring the regulatory compliance of our pharmaceutical products across the EU and Rest of World (RoW) markets. You will collaborate closely with…
Rontis
Company ProfileAbout the company
Rontis, a multinational specialty healthcare corporation, was established in 1986 with a vision to provide the most innovative & trustworthy solutions, aiming to become an international leader in the global healthcare industry.
Workplace
On Site
Sector
Βιομηχανική Παραγωγή
Employment Type
Permanent
Work Time
Full Time
Rontis
Company ProfileAbout the company
Rontis, a multinational specialty healthcare corporation, was established in 1986 with a vision to provide the most innovative & trustworthy solutions, aiming to become an international leader in the global healthcare industry.