Regulatory Affairs Executive
Himont Group · Lahore
Job description
About the role
We are seeking a competent, detail‑oriented Regulatory Affairs Executive with hands‑on experience in the pharmaceutical and nutraceutical sectors to join our team in Lahore.
Key responsibilities
- Prepare, compile, review and submit product registration dossiers in CTD/ACTD format according to regulatory guidelines.
- Coordinate and manage submissions to authorities such as DRAP, PSQCA and DTL, including follow‑ups and responses.
- Handle post‑registration activities like variations, re‑registrations, renewals and licence applications (DML, DSL).
- Process pricing cases through online portals and hard‑copy forms.
- Manage market complaints, ensuring proper documentation, investigation and coordination with relevant departments.
- Maintain accurate regulatory records, submission trackers and compliance files.
Required profile
- Pharm‑D (Doctor of Pharmacy) degree.
- Minimum 3 years of experience in pharmaceutical and nutraceutical regulatory affairs.
- Strong attention to detail and ability to manage multiple assignments efficiently.
Required skills
- Practical knowledge of Pakistan’s pharmaceutical and nutraceutical regulatory requirements.
- Proficiency with digital regulatory portals, especially the DRAP e‑app portal.
- Advanced use of Microsoft Word and Excel.
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Published 1 week ago
Expires 1 month from now
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Himont Group
Lahore
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