Regulatory Affairs Specialist for Pharmaceutical Compliance
4 weeks ago
We are seeking a highly skilled Regulatory Affairs Executive API PHARMA to join our team at Success Vibrant Human Resources & Public Relationship Solutions (SVHRPRS). As a leading provider of HR and PR solutions, we strive to deliver efficient and reliable services to our clients.
The ideal candidate will possess a Bachelor's degree in Pharmacy, Chemistry, or a related field, and have 1 to 3 years of experience in regulatory affairs within the pharmaceutical industry. Strong knowledge of regulatory legislation, guidelines, and practices is essential, as well as familiarity with regulatory submission processes and requirements.
Key Responsibilities
- Develop and implement regulatory strategies to ensure compliance with local and international regulations.
- Review and analyze regulatory guidelines, legislation, and policies.
- Prepare and submit regulatory documents, including registration dossiers, variations, and renewals.
- Coordinate and communicate with regulatory authorities for product registrations, approvals, and inspections.
- Ensure compliance with labeling and promotional requirements for pharmaceutical products.
- Monitor and track regulatory updates and changes that may impact the business.
- Collaborate with cross-functional teams to provide regulatory support and guidance.
- Participate in internal and external audits.
- Maintain regulatory documentation and records.
Requirements
- Bachelor's degree in Pharmacy, Chemistry, or a related field.
- 1 to 3 years of experience in regulatory affairs within the pharmaceutical industry.
- Strong knowledge of regulatory legislation, guidelines, and practices.
- Familiarity with regulatory submission processes and requirements.
- Excellent communication and interpersonal skills.
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