Job Description

Regulatory Affairs Officer / Executive: (BKM) is seeking a Regulatory Affairs Officer to join our team. In this role, you will be responsible for getting new products approved from the FDA and will also be responsible for submitting annual reports and supplements to the agencies. The person should be able to support the product life cycle management, maintenance of marketing authorizations and various other documents for regulated markets. You will also responsible for keeping BKM Internal Regulatory systems up to date and accurate. Job Responsibility: Search for regulation requirements for Pharmaceutical / Nutraceutical product registration in country wise. Prepares and submits applications and reports to applicable regulatory bodies. Responds to requests for information from regulatory bodies. Prepare the dossiers of pharmaceutical and nutraceutical products according to requirements of international regulatory body. Provide technical review of data or reports. Communicate with regulatory authorities, project teams and vendors on regulatory-related matters. Review translations of essential documents subject to clinical trial submission. Track the regulatory project documentation flow. Prepare and review GMP documents like FDR, MFR, MPR, BPR, BMR, PV Protocol and reports. Prepare and review of QC related documents such as RM SPEC, MOA, PM SPEC, FG SPEC, and COA. Keeping updated on current regulatory guidance. Required Qualification & Skills: Bachelor\xe2\x80\x99s Degree in Science field such as chemistry, bio chemistry or pharmacy. Full working proficiency in English. Proficiency in MS Office applications. Ability to learn, plan and work in a dynamic team environment. Communication, collaboration, and problem-solving skills. Experience: 2 to 5 years Location:Ahmedabad, Gujarat (On-site) Benefits:Paid Leaves Job Type: Full-time Salary: 300,000.00 - 500,000.00 per year Benefits:

• Paid time off

• UK shift

• Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)

• Regulatory: 1 year (Preferred)
• Dossier preparation: 1 year (Required)
• Pharma manufacturing: 1 year (Preferred)