
Regulatory Affairs Senior Officer
3 days ago
- Prepare, review, and coordinate CMC sections (Modules 2.3 and 3) of technical dossiers for new product submissions
- Evaluate existing dossiers to ensure compliance with the latest EU and international regulatory guidelines
- Lead the preparation of quality variations and responses to regulatory authorities
- Liaise with internal stakeholders, contract manufacturers, and suppliers to gather and verify required documentation
- Perform gap analyses and propose strategies to address deficiencies
- Provide guidance and technical support to junior Regulatory Affairs Officers
- Contribute to the development of departmental SOPs and maintain up-to-date regulatory databases
- Stay current with global regulatory changes relevant to pharmaceutical quality and CMC submissions
- University degree in Pharmacy, Chemistry, Biology, or a related field
- Minimum of 4 years of experience in Regulatory Affairs with a focus on CMC; 6 years or more is desirable
- Professional experience in the Pharmaceutical Industry, in R&D, QC, or other related areas with strong CMC exposure will also be considered
- Solid understanding of pharmaceutical quality standards and regulatory requirements
- Strong attention to detail, organizational, and analytical skills
- Excellent command of the English language and strong computer literacy
- Experience mentoring or guiding junior colleagues is a plus
- Competitive compensation and benefits package, including health insurance
- Clear opportunities for career advancement and professional growth
- A collaborative and forward-thinking work culture
- The chance to be part of a team that brings innovative medicines to patients globally
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