Regulatory Pharmacist

1 month ago

india Paragon Consulting Full time
Job Description

Overview A leading pharmaceutical company is seeking a highly skilled and detail-oriented Regulatory Pharmacist. The primary responsibility of this role is to manage the registration process of pharmaceutical products with The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria.


The Regulatory Pharmacist will play a crucial role in ensuring compliance with regulatory requirements and maintaining product registration licenses. This role requires a high degree of confidentiality, discretion, and a strong sense of professionalism.

Requirements About the Role

  • Lead the registration process of pharmaceutical products with NAFDAC, including new products, variations, renewals, and amendments.

  • Prepare and submit registration dossiers, ensuring accuracy, completeness, and compliance with NAFDAC regulations and guidelines.

  • Liaise with internal cross-functional teams, including Research & Development, Quality Assurance, Manufacturing, and Marketing, to gather necessary documentation and information for product registration.

  • Submission of periodic safety update reports

  • Communicate effectively with NAFDAC officials and respond to inquiries or requests for additional information during the registration process.

  • Stay updated on changes in NAFDAC regulations, guidelines, and procedures related to product registration and ensure company compliance.

  • Coordinate and participate in regulatory inspections and audits conducted by NAFDAC.

  • Monitor the status of registration applications and provide regular updates to internal stakeholders.

  • Maintain accurate records of product registrations, including documentation of submission, approvals, and renewals.

  • Provide regulatory support and guidance to internal teams on matters related to NAFDAC regulations and product registration.

  • Compliance with post-market surveillance

  • Establishing and maintaining a pharmacovigilance system

About You

  • You possess a Bachelor's or Master's degree in Pharmacy from a recognized institution.

  • You are a Registered Pharmacist with a valid practising license from the Pharmacists Council of Nigeria (PCN).

  • You have 3-5+ years of proven experience in regulatory affairs within the pharmaceutical industry, with a focus on NAFDAC registration processes.

  • You have in-depth knowledge of NAFDAC regulations, guidelines, and procedures for product registration in Nigeria. This is non-negotiable.

  • You are excellent at managing multiple projects simultaneously.

  • Your attention to detail and accuracy in document preparation and submission is exceptional.

  • You possess the capacity to collaborate effectively within cross-functional teams and influence stakeholders to attain regulatory objectives.

  • Your comprehension of pharmaceutical product development, manufacturing, and quality assurance processes is robust.

  • Your communication skills, both verbal and written, are effective, enabling you to interact confidently with internal teams and regulatory authorities.


Benefits Competitive compensation. Opportunity to be a part of a growing, yet established company.

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