Job Description
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Senior 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
Requirements
- Bachelor or Master Degree in Pharmacy with 6-9 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.
Benefits
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
