Pharmaceutical Regulatory Compliance Specialist

4 days ago


Gurgaon, Haryana, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

Job Summary:

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  • We are seeking a highly skilled Regulatory Compliance Manager to lead our regulatory affairs team and oversee the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.">
  • The ideal candidate will have expertise in managing the regulatory process, ensuring accuracy and compliance with regulatory requirements.">
  • Responsibilities include compiling and reviewing ACTD and CTD dossiers, addressing Ministry of Health (MOH) queries, and ensuring timely responses.">
  • Additionally, the candidate must review product artworks and samples to ensure compliance with regulatory requirements.">
  • Liaising with international agents for dossier submission, follow-up, and product registration is also a key responsibility.">
  • Maintaining comprehensive records of technical documentation, product registrations, and related expenses is essential.">
  • The successful candidate will lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met.">
  • Proven experience in regulatory compliance, particularly in pharmaceutical finished formulations for CIS, LATAM, and African markets, is required.">
  • Strong organizational skills and attention to detail are necessary for this role.">
  • Effective coordination with international agents and management of dossier submission and registration processes are also key responsibilities.">
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Key Qualifications:

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  • Regulatory compliance expertise, particularly in pharmaceutical finished formulations.">
  • Experience in managing regulatory affairs teams and overseeing the regulatory process.">
  • Excellent organizational skills and attention to detail.">
  • Ability to work effectively with international agents and coordinate dossier submissions.">
  • Strong communication and problem-solving skills.">
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Benefits:

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  • Opportunity to work on high-profile regulatory projects.">
  • Collaborative and dynamic work environment.">
  • Professional development opportunities.">


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