Regulatory Affairs Officer
6 meses atrás
**We are seeking a highly motivated and detail-oriented Regulatory Affairs Officer to join our pharmaceutical company. **The Regulatory Affairs Officer will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products. This position requires strong attention to detail, excellent communication skills, and the ability to work collaboratively with cross-functional teams.
**Responsibilities**:
- Prepare and submit regulatory documents (INDs, NDAs, BLAs, MAAs, etc.)
- Ensure compliance with laws, regulations, and guidelines established by regulatory agencies and national regulatory authorities
- Collaborate with cross-functional teams during product development to ensure regulatory compliance from the early stages of research and development through to commercialization
- Oversee the development of product labeling and packaging materials to ensure compliance with regulatory requirements
- Manage regulatory aspects of clinical trials, including obtaining regulatory approvals, ensuring compliance with Good Clinical Practice (GCP) guidelines
- Monitor and report adverse events and other safety issues associated with pharmaceutical products to regulatory authorities as required by pharmacovigilance regulations
- Work closely with quality assurance and quality control teams to ensure that pharmaceutical products are manufactured, tested, and distributed in compliance with current Good Manufacturing Practice (cGMP) regulations
- Prepare for and participate in regulatory inspections and audits conducted by health authorities
**Experience**:
- Bachelor’s degree in pharmacy, life sciences, or related field
- 3+ years of regulatory affairs experience in the pharmaceutical industry
- Strong knowledge of EU/UK and other major markets’ regulatory requirements
- Experience with regulatory submissions and health authority interactions preferred
- Familiarity with pharmacovigilance regulations and adverse event reporting is a plus
- Labeling and product information updates experience
- Lifecycle Maintenance/Regulatory Support Experience:
- External and unannounced audits
- Internal requests for technical and regulatory information
- Technical/Site Transfer Applications
- Marketing Authorisation Applications
- Compliance Management Experience
- Administrative Experience with software packages (e.g., Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, PromoMat) for correspondence, document production, spreadsheet/database maintenance, and information retrieval
- Ability to work independently and collaboratively, with attention to detail
- Good IT, organizational, and communication skills
**Salary**: 20,000.00€ - 23,000.00€ per year
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