Regulatory Affairs Specialist
il y a 20 heures
We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical company, ProductLife Group. The successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.
Key Responsibilities:- Regulatory Document Preparation: Prepare and submit regulatory documents (INDs, NDAs, BLAs, MAAs, etc.) to ensure compliance with regulatory requirements.
- Regulatory Compliance: Ensure compliance with laws, regulations, and guidelines established by regulatory agencies and national regulatory authorities.
- Cross-Functional Collaboration: Collaborate with cross-functional teams during product development to ensure regulatory compliance from the early stages of research and development through to commercialization.
- Product Labeling and Packaging: Oversee the development of product labeling and packaging materials to ensure compliance with regulatory requirements.
- Regulatory Aspects of Clinical Trials: Manage regulatory aspects of clinical trials, including obtaining regulatory approvals, ensuring compliance with Good Clinical Practice (GCP) guidelines.
- Pharmacovigilance: Monitor and report adverse events and other safety issues associated with pharmaceutical products to regulatory authorities as required by pharmacovigilance regulations.
- Quality Assurance and Control: 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.
- Regulatory Inspections and Audits: Prepare for and participate in regulatory inspections and audits conducted by health authorities.
- Education: Bachelor's degree in pharmacy, life sciences, or a related field.
- Experience: Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
- Language Skills: Excellent written and verbal communication skills in French and English, with the ability to effectively communicate complex regulatory requirements to cross-functional teams.
- Skills: Proven ability to work independently and collaboratively in a fast-paced environment, with a strong attention to detail and accuracy.
- Preferred Qualifications: Experience with regulatory submissions and interactions with health authorities is preferred. Familiarity with pharmacovigilance regulations and adverse event reporting is a plus.
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