Regulatory Manager
-Pharmaceuticals
Position Overview:
Product Registration: Compiling and submitting dossier documents for new product registration and renewals to regulatory bodies.
Compliance Strategy: Developing strategies to meet regulatory requirements and ensuring adherence to local/international regulations (e.g., NMRA Act, Sri Lanka).
Liaison Officer: Acting as the primary contact between the pharmaceutical company, regulatory agencies, and foreign partners.
Labeling and Technical Texts: Reviewing and ensuring accuracy of packaging, inserts, and technical documentation.
Team Leadership: Guiding, mentoring, and supporting the regulatory team for accuracy in submissions.
Applicant Profile:
Degree in Bio science/Pharmaceuticals.
Minimum 8-10 years of hands-on experience in regulatory roles, preferably in a healthcare or pharmaceutical manufacturing environment. (Should having strong knowledge NMRA process is mandatory.)
Minimum of 2-3 years Assistant Manager/Manager Regulatory position.
Deep understanding of regulatory requirements across surgical, pharma, and wellness product categories.
Strong project management and organizational skills.
Exceptional attention to detail, particularly in documentation and legal submissions.
Effective communication and negotiation skills with internal and external stakeholders.
Ability to work independently and collaboratively in cross-functional teams.
The selected candidate will receive an attractive remuneration package, in keeping with the market standards.
Email your CV with details of two non-referees to hr4@konnecting.biz
Application will be treated confidentially
& the shortlisted applicants will be contacted.
