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Regulatory Affairs Manager

4 months ago

Mumbai, India Medico Remedies Pvt. Ltd. Full time

Company Description

Medico Remedies Ltd is a rapidly growing Finished Pharmaceutical Formulations company for tablets, capsules, external preparations focused on increasing its presence in the developing markets of the world. We are looking for competent and experienced people to join in our growth journey.


Role Description

This is a full-time on-site role as a Regulatory Affairs Manager at Medico Remedies Ltd. located in Andheri, Mumbai. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with government regulations and guidelines in regards to pharmaceutical products. Your duties will include preparing and submitting regulatory documents, monthly status of registered and under renewal products of every country, conducting research on current regulations, and staying up-to-date with industry trends and changes. You will also collaborate with cross-functional teams to ensure product quality and regulatory compliance throughout the development process.


Qualifications

  • Bachelor's degree in Pharmacy, Life Sciences, or a related field
  • Proven experience in regulatory affairs within the pharmaceutical industry
  • Strong knowledge of local and international regulations and guidelines (ROW- LATAM, ASEAN, CTD,)
  • Excellent communication and teamwork skills
  • Attention to detail and strong analytical skills
  • Ability to prioritize and multitask in a fast-paced environment
  • Ability to adapt to changing regulations and requirements
  • Strong problem-solving and decision-making abilities