Intas Pharmaceuticals, a leading global pharmaceutical company, is expanding its biopharmaceutical capabilities and is seeking talented professionals to join its Regulatory Affairs department. The company is conducting a Virtual Walk-In Drive for the positions of Senior Executive, Assistant Manager, and Manager in Regulatory Affairs. This is an excellent opportunity for individuals with 5-12 years of experience in Biosimilars Regulatory Affairs. The virtual interviews will be conducted via MS Teams, and the selected candidates will be part of Intas' growth journey, contributing to its biopharma operations in Ahmedabad.
Job Details:
Position: Sr. Executive/Asst. Manager/Manager - Regulatory Affairs Department: Regulatory Affairs (Biosimilars) Job Location: Ahmedabad, Biopharma Plant Mode of Interview:- Virtual Walk-In Drive via MS Teams
- 20th October 2024 (Sunday)
- Time: 09:00 am to 06:00 pm
- 5 to 12 years of experience in Biosimilars Regulatory Affairs
- M Pharmacy or MSc in Biotechnology
Purpose of Job
Accountable for preparation of submissions to regulated markets for licenses/approvals and coordinating with all cross-functional teams for regulatory filings.
Skill Required
Relevant experience in CMC writing, eCTD publishing and regulatory operations
Roles and Responsibilites
- Ensure preparation, review and submission of CTD sections in compliance with requirements of EMA, USFDA and other global markets.
- Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies
- Registration application preparation including administrative documents and GMP audit support for global markets
- Publishing of drug registration applications and lifecycle management submissions
- Preparation of gap analysis for the registration in regulated and semi regulated markets.
- Assist in establishing and tracking effective change control management coming for regulatory review and approval.
- Actively participate in Regulatory Information management system assessment, and implementation.
- To review CMC documents for its compliance and adequacy of information for regulated market filing.
- Review and assessment of change controls and related variation submissions to global markets
Qualification Required
- Bachelor/Masters in the field of Biotechnology/Biological sciences/Pharmacy/Regulator Affairs
- RAC certification will be an added advantage
Competencies
- Intas - Action Oriented
- Intas - Customer Focus
- Intas - Dealing with Ambiguity
- Intas - Problem Solving
- Intas - Time Management
Relevant skills / Industry experience
- 6-8 years of work experience in Regulatory Affairs for Biosimilars/biologics for global markets
Intas Virtual Walk-In Drive for Regulatory Affairs - Sr. Executive/Asst. Manager/Manager[/caption]
