Regulatory Affairs Executive
Job Summary:
BKM Health Pvt Ltd is seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our growing team. In this role, you will gain hands-on experience in preparing and submitting regulatory dossiers to various international regulatory agencies, including the US FDA, EMA, and Health Canada. This is an excellent opportunity for a driven individual with a passion for regulatory affairs to advance their career in a dynamic and challenging environment.
Job Summary:
As a Regulatory Affairs Executive at BKM Health, you will play a vital role in ensuring our products comply with all applicable regulations and guidelines. You will be responsible for preparing, compiling, and reviewing regulatory submissions, coordinating with internal teams, and staying up-to-date on evolving regulatory requirements. This role offers significant opportunities for professional growth and development in the field of international regulatory affairs.
Responsibilities:
- Prepare, compile, and review eCTD dossiers for ANDA, NDA, MAA, and ANDS submissions.
- Coordinate with Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Manufacturing, and Packaging teams to ensure accurate and complete documentation.
- Submit regulatory applications to the US FDA, EMA, Health Canada, and other global regulatory authorities.
- Publish and validate regulatory submissions using tools such as Extedo, Lorenz docuBridge, or similar systems.
- Ensure the technical accuracy and completeness of eCTD sequences.
- Troubleshoot validation errors and resolve issues prior to final submission.
- Prepare documentation for post-approval changes, including CMC variations, labeling updates, and packaging modifications.
- Submit supplements, amendments, and variations to regulatory agencies (e.g., FDA PAS, EMA Type IA/IB/II).
- Draft high-quality responses to regulatory inquiries.
- Stay informed and updated on current ICH, FDA, and EMA guidelines and regulations.
- Maintain accurate regulatory trackers, approval databases, and documentation.
- Support regulatory audits and inspections.
Requirements:
- Bachelor’s or Master’s degree in Pharmacy or a related scientific field.
- 1.5–2 years of experience in Regulatory Affairs, specifically related to regulated markets (US, EU, Health Canada).
- Strong knowledge of USFDA, EMA, and ICH regulatory frameworks and guidelines.
- Proven experience in dossier compilation, eCTD publishing, and regulatory submissions.
- Excellent written and verbal communication skills.
- Strong documentation and organizational skills.
- Analytical and problem-solving abilities.
- Ability to work effectively both independently and as part of a team.
Benefits:
BKM Health Pvt Ltd offers a competitive compensation and benefits package, which may include:
- Competitive salary
- Opportunities for professional growth and development in regulated market submissions.
- Exposure to global regulatory guidelines and audit processes.
- A collaborative and supportive work environment.
- Opportunities for advancement within the company.
- Health Insurance
- Paid Time Off
How to Apply:
If you are a qualified and motivated individual seeking a challenging and rewarding career in Regulatory Affairs, we encourage you to apply. Please submit your resume and cover letter for consideration. We look forward to hearing from you!