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Regulatory Affairs Specialist
il y a 4 semaines
We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join ProductLife Group as a key member of our pharmaceutical team.
About the RoleThe successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally. This involves preparing and submitting regulatory documents, ensuring compliance with laws, regulations, and guidelines established by regulatory agencies and national authorities.
Key Responsibilities- Regulatory Document Preparation: Prepare and submit regulatory documents (INDs, NDAs, BLAs, MAAs, etc.) to ensure timely and accurate submissions.
- Compliance Management: Ensure compliance with laws, regulations, and guidelines established by regulatory agencies and national authorities.
- Cross-Functional Collaboration: Collaborate with cross-functional teams during product development to ensure regulatory compliance from early stages through commercialization.
- 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 and 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.
- Education: Bachelor's degree in pharmacy, life sciences, or a related field.
- Experience: Minimum 5 years of experience in regulatory affairs within the pharmaceutical industry.
- Skills: Strong knowledge of regulatory requirements for drug development, approval, and marketing in the EU and other major markets.
- Language: Excellent written and verbal communication skills in English.
- Soft Skills: Proven ability to work independently and collaboratively in a fast-paced environment with strong attention to detail and accuracy.
- Competitive Salary: $80,000 - $110,000 per annum based on experience.
- Benefits Package: Comprehensive benefits package including health insurance, retirement plan, and paid time off.
ProductLife Group is a leading pharmaceutical company dedicated to improving patient outcomes through innovative products and services. Our team is passionate about making a difference in people's lives, and we're looking for talented individuals like you to join us on this journey.
