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Assistant Manager Regulatory Affairs (Regulated Market)

5.00 to 10.00 Years   Mohali   04 Jun, 2023
Acme Services Private Limited
Job LocationMohali
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaLegal Practice
EmploymentTypeFull-time

Job Description

    Assistant Manager Regulatory Affairs (Regulated Market)Job descriptionNote: Required Candidate from Regulated Market and Pharmaceutical Background only (US/UK/EUROPE etc).Compile and review of ANDAs & 505(b)(2) applications (pIND meetings, IND submissions, CT protocol & amendments, iPSP, Brand Name submissions) with USFDA, MAA applications with EU and ANDS submission with TPD Canada.Have wide range of experiences on various dosage forms parental products (Simple and complex) and Oral formulations tablet, capsules, oral solutions, and suspensions.Experience in submission of pre-ANDA meetings for complex products with USFDA, scientific advice meeting with EU countries, pre-submission meetings with TPD and ANVISA.Compile and review of DMFs for peptide drug substancesExperienced with handling drug device combination regulations and understand the requirements for submission of Threshold Analysis report and Human Factor Engineering studies protocols and reports. Review and approve of Design History File documents. Submission of GSPR dossier inline with EU MDR to Notified Bodies for drug device combination products (Prefilled syringes and disposable pens)To assure consistency and adequacy of submissions in line with current regulatory requirements/expectations. Provide strategic regulatory guidance on pre-approval & post-approval activities/submissions.Ensure timely response to the deficiencies received from the agencies. Communicate with the regulatory authorities for bioequivalence recommendations & inactive ingredient levels which are essential during the product development stage before the submission of an application.Manage and assign responsibilities to the team within the regulatory group. To communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissions.Life cycle management of products to include renewals, reviewing & approving the change controls and ensure product continuity through filing and timely approvals of variations. Support the continuity activities through co-ordination with various stakeholders.Ensure product compliance with respect to approvals and regulatory requirements.Required Candidate profile

Keyskills :
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