TCS Regulatory affairs jobs for B pharm & M pharma Candidates

TCS hiring Regulatory Technical Services Professionals.

Location- Mumbai / Bangalore / Delhi / Gurgaon

Education- B Pharmacy / M Pharm

Experience – 5 to 10 years. A maximum of 10 years of Regulatory Affairs pharmaceutical or related experience is required. US/EU experience will be preferred.

Job Role:

Be responsible for leading the operational management and delivery of regulatory submissions to support the development, registration, and compliance of products.

Collaborate on the coordination of the preparation and maintenance of regulatory submissions and filings. Lead Submission Team meetings and influence stakeholders, as applicable.

Create and manage the Dossier Plan(s)/Submission Packages in line with the regulatory strategy. Seek input from regulatory therapeutic areas, functional area representatives, and key stakeholders. Provide guidance to project team members.

Assess, prepare and compile regulatory submissions (e.g. safety labeling changes, CMC, administrative, safety etc), ad hoc reports and maintain the life cycle of currently marketed products.

Assist in the preparation and submission of larger submissions including new applications, variations, line extension etc

Assist in the preparation and review of responses to and Notice of Deficiency [NOD]), RFPs in a timely manner.


CORE / TECHNICAL COMPETENCY REQUIREMENTS :-

Basic knowledge of the drug development process is required.

Knowledge of US/EU/Canada/Australia and any other major regulated countries drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions is required.

Experience in eCTD / NeeS submissions will be preferred but not limited to these.

Experience with managing the operational aspect of all types of submission like; MAA, ANDA, NDA, NDS, SNDS, etc

Demonstrated project or submission management capabilities.

Demonstrated effective interpersonal, teamwork, and communication skills.
Experience preparing and obtaining approval of therapeutic / labeling submissions.

Application Link & More information Check below Link

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