Established in Hyderabad, India in 1978, Gland Pharma has grown over the years from a contract manufacturer [HK1] of small volume liquid parenteral products, to become one of the largest and fastest growing generic injectables manufacturing companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets. We operate primarily under a business to business (B2B) model and have an excellent track record in the pharmaceutical research and development, manufacturing and marketing of complex injectables. This presence across the value chain has helped us witness exponential growth. We have a professional management team and one of our Promoters, Shanghai Fosun Pharma, is a global pharmaceutical major.Injectables manufacturing company – Gland Pharma Limited
We are present in sterile injectables, oncology and ophthalmic segments, and focus on complex injectables including NCE-1s, First-to-File products and 505(b)(2) filings. Our products are currently delivered via liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags and drops; and efforts are underway to augment additional manufacturing capabilities in complex injectables such as peptides, long-acting injectables, suspensions and hormonal products. We are also in the process of including new delivery systems such as pens and cartridges into our product portfolio.
Our ethos at work is to consistently focus on meeting diverse injectable needs with high-quality products at attractive price points. On this strong plinth of looking ahead, we have successfully and repeatedly harnessed our R&D expertise in synthesizing complex molecules to produce complex injectables. Enabling us to develop niche products for diverse markets worldwide.
Apply:
Send your updated CV to saranya.ramesan@glandpharma.com
JOB DESCRIPTION
- Job Position : DRA – Labelling US Market
- Experience : 6 to 9 Years
- Qualification : B. Pharmacy / M. Pharmacy
- Job Location : Hyderabad.
Details :
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Drug Regulatory Affairs (Labelling – US Market)
Roles & Responsibilities:-
• Preparation of text matter for artworks/Labels. Review and Approval of Artworks, change controls and updating for all Regulatory Submissions.
• Responsible for preparation and submission of CBE 0 labelling supplements for approved products to USFDA.
• Initiation of Change Controls regarding Artworks, compilation of eCTD modules and SPL Publication to USFDA.
• Approval of commercial artworks in software. Annual establishment registration and BNCC certification & Approval of Print Proofs.
• Responsible for eCTD Submission, Publication and product life-cycle management. Responsible for allotting NDC numbers, etc.
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