Executive - Regulatory

1 week ago

Navi Mumbai, Maharashtra, India Shalina Healthcare Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • To prepare dossiers for product registration and renewal as per the scheduled time in African and Middle East countries in Regional as well as CTD formats as per the requirements for registration purpose.
  • Variation filing of the products considering all the changes in Finished product.
  • Local FDA activity as and when required.
  • CDSCO activity as and when required.
  • To check artworks for regulated and semi regulated countries for defined countries.
  • To co-ordinate for documents and samples for regulatory submissions with manufacturing locations - LL & TP.
  • Handling of queries pertaining to regulatory submissions from various regulatory authorities.
  • Maintain and update regulatory archives and Regulatory Database of the identified countries.
  • To arrange IMC & country embassy of legal documents.
  • Handling specific New products projects.
  • Any other work assigned by Regulatory Head/Technical Head from time to time.

Preferred candidate profile

  • Bachelors/Masters degree in Pharmacy, Life Sciences, or a related discipline.
  • Minimum 4+ years of experience in Regulatory Affairs, specifically within African and Middle Eastern markets.
  • Familiarity with regulatory frameworks (FDA, CDSCO, ICH, CTD, etc.).
  • Expertise in dossier preparation, submission, and variation filing.
  • Strong communication and coordination skills to engage with regulatory bodies and manufacturing units.

Perks and benefits

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