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Job Description & How to Apply Below
Global RA
Drafting of the eCTD sections for regulated market such Europe, USA, Canada, Brazil etc. for biological products (Biosimilars)
Preparation of the briefing book for scientific advice, for EMA, UK HMRA etc.
Preparation of the briefing book for biological development meetings like BPD Type 2, Type 3 and Type 4
Handling the customer/regulatory queries
Regulatory inputs for developmental stages of the product life cycle
Preparation of pre-submission meetings packages
Collation of the modules for BLA/NDA/EU MAA etc.
Sequence preparation and publishing activity for regulated market using eCTD software
Extensive review of the documents and the sections
Should be able to guide the Team of the RA for section drafting the document review
Good in technical writing
In depth understanding of global regulatory for biosimilars
Should be through with regaultory requirements
Understanding of product lifecycle
Strong communicaiton skills;
Good capabilites to guide/mentor the Team members
Skills
Strong interpersonal skills to collaborate across functions and levels.
Qualification :
Master's degree in a Pharmacy, Life Sciences, or a related field (e.g., Biology, Biotechnology, Biochemistry, Pharmacy).
Experience : 10 to 12 years in biotechnology industries with global regulatory affairs role Minimum 3 years in global RA
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