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Regulatory Affairs Specialist
Il y a 2 mois
We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company, ProductLife Group.
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.
- Clinical Trials Management: 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.
- Regulatory Knowledge: Strong knowledge of regulatory requirements for drug development, approval, and marketing in the EU, and other major markets.
- Communication Skills: Excellent written and verbal communication skills in French and English, with the ability to effectively communicate complex regulatory requirements to cross-functional teams.
- Attention to Detail: Proven ability to work independently and collaboratively in a fast-paced environment, with a strong attention to detail and accuracy.
- Regulatory Submissions: Experience with regulatory submissions and interactions with health authorities is preferred.
- Pharmacovigilance Regulations: Familiarity with pharmacovigilance regulations and adverse event reporting is a plus.
