Regulatory Affairs Responsible
973,333 – 1,297,778 Ft / month
Employer · Opella
Pharmacist
Chemist
Licensing officerFull-timeBudapest
As a Regulatory Affairs CMC Responsible, you'll bring your expertise, curiosity and drive to make health simpler, smarter and more human. The Regulatory Responsible -- CMC plays a key role in leading Chemistry, Manufacturing and Control activities within the regulatory team, ensuring supply continuity and driving effective regulatory strategies.
Tasks
- Lead the preparation, review and optimization of CMC regulatory dossiers to support global submissions and lifecycle management
- Coordinate internal and external stakeholders involved in CMC documentation and ensure consistency and quality of submissions
- Define and drive regulatory strategies for product changes, ensuring timely approvals across multiple markets
- Assess regulatory impact of manufacturing or process changes and actively participate in change control activities
- Ensure alignment between CMC dossiers and manufacturing practices at CMOs, maintaining compliance with global regulations
- Support interactions with Health Authorities, including preparation of responses and regulatory documentation
- Act as a key regulatory interface across global and local teams, supporting product launches and business opportunities
Requirements
- Proven experience in CMC writing and/or Regulatory Affairs within the pharmaceutical industry
- Experience in a GMP environment (Quality, Manufacturing, Development, or QC), with strong exposure to compliance topics
- Strong communication skills, with the ability to collaborate effectively across cross-functional teams
- Ability to manage multiple priorities and timelines in a fast-paced environment
- High level of organisation, attention to detail, and problem-solving mindset
- Self-motivated, proactive, and able to work independently
- Solid knowledge of global regulatory requirements (EU, FDA, ICH, China)
- Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field
- Fluency in English (written and spoken)