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 Sciences
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 internal departments and external stakeholders to support the preparation, submission, and maintenance of regulatory dossiers in eCTD format.
Key Responsibilities
Coordinate with internal departments and external partners to gather data for EU and RoW 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.
Qualifications & Skills
University degree in Chemistry, Chemical Engineering, Biology, or Pharmaceutical Studies.
Minimum of 2 years’ experience in Regulatory Affairs and/or CMC (pre- and post-approval).
Solid understanding of EU regulatory framework, ICH guidelines, GMP, and GLP standards.
Fluency in English (written and spoken)
Computer literate; Strong proficiency in MS Office
Strong organizational and time-management skills with the ability to work under pressure.
Excellent communication and interpersonal skills.
About 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.
About 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.