Company Overview
Success Vibrant Human Resources & Public Relationship Solutions (SVHRPRS) is a leading provider of HR and PR solutions for businesses and organizations at various levels. With a dedicated team, we strive to meet the needs of our clients by offering efficient and reliable services.
Job Overview
We are hiring a Regulatory Affairs Executive API PHARMA to ensure compliance with regulatory requirements for the manufacturing and distribution of pharmaceutical products.
Qualifications and Skills
- Bachelor's degree in Pharmacy, Chemistry, or a related field
- Junior: 1 to 3 years of experience in regulatory affairs within the pharmaceutical industry
- Knowledge of regulatory legislation, guidelines, and practices
- Familiarity with regulatory submission processes and requirements
- Strong attention to detail and ability to interpret complex regulatory documents
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively in a fast-paced environment
- Experience with regulatory inspections and audits
- Proficient in Microsoft Office Suite
Roles and 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
