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