Regulatory Affairs Manager/Executive | Alder Biochem | Dehradun

Job Description

Experience:-10 + years

Salary:- negotiable

Job Location-Dehradun

Job Designation-Manager(10 to 15 years) / Executive(5 to 8 years)

Note: Required Candidate from Regulated Market and Pharmaceutical Background only (US/UK/EUROPE etc).

Roles and Responsibilities:

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 a wide range of experiences with various dosage soft gel products (Simple and complex).
• Experience in the submission of pre-ANDA meetings for complex products with the USFDA, scientific advice meetings with EU countries, and pre-submission meetings with TPD and ANVISA.
• Compile and review of DMFs for peptide drug substances.
• Experienced with handling drug-device combination regulations and understanding the requirements for submission of Threshold Analysis reports and Human Factor Engineering studies protocols and reports.
• 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. 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 ensuring product continuity through filing and timely approvals of variations. Support the continuity activities through coordination with various stakeholders.
• Ensure product compliance with respect to approvals and regulatory requirements.
• Review and approve of Design History File documents. Submission of GSPR dossier in line with EU MDR to Notified Bodies for drug-device combination products (Prefilled syringes and disposable pens)