Junior Serialization & Laboratory Software Platforms Administrator
Demo S.A.
Full time
Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center
Demo S.A.· Regulatory Affairs
About this role
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Associate to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for Europe and other global markets for sterile, non-sterile and oral solid/liquid products. This position is based at Hyderabad, India.
Responsibilities:
- Understanding of Regulatory strategy and documentation requirements for EU variations including renewals, extensions for Sterile (SVP, LVP, lyophilized, ophthalmic etc.), non-sterile and oral solid/liquid products.
- Collect, prepare, compile regulatory documentation, for the product’s lifecycle maintenance (administrative, quality, safety variations and renewal procedures).
- Prepare and coordinate responses to Deficiency Letters (DLs) and other CMC-related regulatory queries in collaboration with cross-functional teams
- Preparation of module 1 documentation for as per assigned timelines for out-licensing and in-licensing products in EU countries
- Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
- Liaise with external Regulatory authorities as required
- Act as responsible Regulatory Team member for assigned regulatory projects
- Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products
- Bachelor or Master Degree in Pharmacy with 3+ years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization.
- Knowledge of CMC and global regulatory guidelines for Sterile (small & large volume parenteral, aqueous solution, lyophilized product, sterile powder etc) and oral solid/liquid dosage form.
- Strong organization skills, multi-tasking and able to meet deadlines.
- Effective communication and relationship management.
- Ability to work under pressure, resilience.
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center position at Demo S.A.?
The salary for this Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center role at Demo S.A. is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center position at Demo S.A. located?
This Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center role at Demo S.A. is based in Hyderabad, Telangana, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center role at Demo S.A. full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center role in the Regulatory Affairs department at Demo S.A..
Which team or department does the Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center at Demo S.A. belong to?
This Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center position is part of the Regulatory Affairs department at Demo S.A.. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center position at Demo S.A.?
Click the "Apply Now" button on this page. You will be redirected to Demo S.A.'s official application portal hosted on workable where you can submit your application directly.
When was the Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center job at Demo S.A. posted?
This Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center position at Demo S.A. was posted on Feb 25, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center
Demo S.A.
You'll be redirected to Demo S.A.'s official application page on workable.