Regulatory Affairs Lead - NCE

Job Description:

Responsibilities

• Preparation & filing of orphan drug designation application, priority review applications, rare-disease application with various regulatory agencies based on the product need.

• You will be responsible for dossier finalization, by finalizing scope, initiating projects with relevant stakeholders, planning, monitoring activities, and reviewing content for finalization. You will identify known risks and propose mitigation plans, as well as communicate and align with the overall product positioning in appropriate governance forums.

• You will be responsible for filing and obtaining approval for regulatory applications by ensuring the timely filing, deficiencies management and approval for various studies and authorizations, and providing strategy and positioning information for query responses. Additionally, you will be involved in follow-ups with partners, affiliates, to ensure timely approvals.

• You will be responsible for liaison with partners, cross functional teams, and commercial teams, providing guidance on regulatory requirements and positioning information in dossiers and query responses. This involves participation in program / project / governance forums and reviewing product development plans.

• You will engage in external liaison with partners / affiliates and health agencies to ensure accurate information is shared with regulators. Proactive management and response to query responses within specified turnaround timelines and proper archiving of reference documents for future use are also part of your responsibilities.

• You will be responsible for preparing and reviewing controlled correspondences, briefing books, and meeting packages to obtain clarity on regulatory issues and provide regulatory strategy notes and due diligence for product development.

• You will be responsible for timely identification of open issues and anticipated questions on regulatory submissions, ensuring compliance and avoiding delays in approval.

• You will be responsible for reviewing and closing change notifications (CRNs) for products under development, review, and launch, in consultation with vertical head.

• You will be responsible for Providing launch support by reviewing launch-related documents and ensuring critical points are addressed in consultation with vertical head.

• You will be responsible for interacting with internal and external customers to provide timely regulatory guidance and support for submissions.

• You will be responsible for providing real-time regulatory guidance and updates to partners & cross-functional teams to ensure compliance with current regulatory requirements during product development.

Qualification & Experience

• Educational qualification: A Master’s degree in Science or Pharmacy.