Regulatory Affairs Executive API PHARMA

3 weeks ago


ahmedabad, India Success Vibrant Full time

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





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