Regulatory Affairs Executive

We are seeking a detail-oriented and motivated Regulatory Affairs Executive with hands-on experience in the pharmaceutical and nutraceutical industries to join our team. The ideal candidate will be responsible for managing regulatory submissions, ensuring compliance with local regulatory authorities, and maintaining accurate documentation to support product registrations and licensing activities. This role requires strong coordination skills and the ability to handle multiple regulatory tasks efficiently.

Key Responsibilities

- Prepare, compile, review, and submit product registration dossiers in CTD/ACTD format according to applicable regulatory requirements and guidelines.
- Manage pricing cases through online portals as well as in hard copy format.
- Coordinate and manage regulatory submissions to relevant authorities such as DRAP, PSQCA, and DTL, ensuring timely follow-ups and responses.
- Handle post-registration variations, product re-registrations, renewals, and other regulatory updates.
- Prepare and process applications for regulatory licenses, including Drug Manufacturing Licence (DML) and Drug Sale Licence (DSL), along with their renewals.
- Oversee day-to-day regulatory affairs activities to ensure compliance with applicable laws, rules, and guidelines.
- Collaborate with relevant departments to manage market complaints, ensuring proper documentation, investigation, and follow-up.
- Maintain accurate regulatory records, product documentation, submission trackers, and compliance-related files.

Required Qualifications

- Pharm-D (Doctor of Pharmacy) degree.
- Minimum of 3 years’ experience in pharmaceutical and nutraceutical regulatory affairs.

Required Skills and Competencies

- Practical knowledge of pharmaceutical and nutraceutical regulatory requirements in Pakistan.
- Proficiency in using digital regulatory portals, particularly the DRAP e-app Portal.
- Strong command of MS Office applications, especially Microsoft Word and Excel.
- Excellent documentation, communication, coordination, and follow-up skills.
- High attention to detail and the ability to manage multiple regulatory assignments efficiently.

Location: Lahore

Interested candidates are encouraged to apply by submitting their updated CV for consideration.