Anthem BioSciences Recruitment Notification for REGULATORY CMC – BIOLOGICALS DIVISION Working Experts

About the Company : Anthem Biosciences is one of India’s leading vertically integrated biopharmaceutical research and manufacturing organizations, offering end-to-end services and a wide range of chemical and biological therapeutic products. We cater to biopharmaceutical, healthcare, and academic institutions across the globe. Our 100+ acre campus spread over 5 sites and 20 blocks, houses state-of-the-art R&D centers and CGMP compliant manufacturing units. Our manufacturing units have been successfully audited and approved by USFDA, DCGI, and other regulatory agencies.

At Anthem, we are increasing our focus on the development, manufacturing, and commercialization of a wide range of

biological products expressed from both microbial and mammalian cells. We have carved our niche in the CDMO space working with global clients for both biosimilars and NBES. We are expanding our product portfolio, manufacturing. infrastructure and market reach in this highly specialized therapeutic segment. We are looking for biopharma professionals who would like to be part of this exciting journey.

Department: Regulatory Sciences / CMC – Biosimilars / Biologics

Qualification: Bachelors / Masters in Lifesciences

Experience: 5-7 years’ experience in Biosimilars/Biologics Regulatory sciences

Requirement:

Strategically planning, writing and compilation of regulatory CMC documents for Biosimilars/ Vaccines product development (Structural and functional development/analytical similarity/comparability studies/method validations/qualifications including lifecycle managements.

Experience in handling Biological products / Biosimilars / Vaccines / mAbs.

Experienced in coordination of regulatory activities with involved internal departments or external CMOS /CROS / license partners.

Development and implementation of CMC regulatory strategies for product development and product lifecycle management.

Authoring and review of Pre-submission meeting requests & scientific advisory briefing packages for biological products.

Authoring and review of CMC packages for submissions to INDS/BLAS/NDSS/MAA for Biological products.

Strong knowledge of all the modules of CTD is desirable.

Strategy and preparation of responses to regulatory queries.

Experience in change control evaluation and post approval submission strategies.

Gap analysis & authoring of Supplements/Amendments/Variants/Renewals/Annual reports to regulatory authorities.

Regulatory compliance check of documents and evaluation of internal documents.

Excellent communication skills.

LAST DAY FOR SUBMISSION: 27TH MARCH 2022

SEND YOUR CV’S TO Anthem BioSciences HR mail Id CAREER@ANTHEMBIO.COM

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