Torrent Pharma, a leading player in the pharmaceutical industry, is currently hiring for
Assistant Manager/Executive positions in Regulatory Affairs at their Gandhinagar, Gujarat location. If you have
4 to 12 years of experience and hold an
M Pharmacy or
MSc degree, this could be a fantastic opportunity to grow your career in regulatory affairs, particularly in handling
EU and US market approvals.
As part of their regulatory affairs team, you’ll work with industry experts and contribute to critical regulatory processes that impact drug development and approvals. This is an excellent chance to gain exposure to
pre- and post-approval submissions, dossier compilations, and regulatory processes across various markets and dosage forms.
Open Positions: Assistant Manager/Executive - Regulatory Affairs
Key Responsibilities:
- - Pre- and Post-Approval Submissions: Responsible for handling regulatory submissions for both EU and US markets, including Module 1, 2 & 3 dossier compilations.
- - Dosage Form Expertise: Manage regulatory affairs for multiple dosage forms such as solid oral, topicals, injectables, suspensions, ophthalmics, and peptides.
- - EU Regulatory Experience: Hands-on experience in DCP, MRP, National phase handling, and post-approval variation compilations for the EU market.
- - US Regulatory Experience: Expertise in ANDA submissions, PAS/CBE-30, annual report compilations, and label preparation for the US market.
- - eCTD Compilation: Experience in electronic Common Technical Document (eCTD) submissions will be an added advantage.
- - Query Responses and Tracking: Respond to regulatory queries and track all submission documents to ensure timely approvals.
Qualifications and Requirements:
- - Education: M Pharmacy or MSc
- - Experience: 4 to 12 years of relevant experience in regulatory affairs, with a focus on pre- and post-approval processes for EU and US markets.
- - Skills: In-depth knowledge of regulatory submission procedures, excellent organizational skills, and the ability to work across multiple dosage forms and regions.
Location:
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Torrent Pharma Hiring for Regulatory Affairs - Assistant Manager/Executive[/caption]
How to Apply:
Interested candidates can send their CVs to devalmodi@torrentpharma.com
https://pharmastuff.org.in/job/torrent-pharma-regulatory-affairs-assistant-manager-executive
