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

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.

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Regulatory Affairs Post-approval Senior Associate

Job Description

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