Manager/Sr. Manager-Regulatory Affairs

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose:

Regulatory planning to meet the affiliate and responsible countries business needs, management & compliance of Regulatory tools as per functional processes. Responsible and accountable for regulatory activities and performances in registering new products (including product line extensions) and new indications. Prepare submissions and gain approval of new products (including product line extensions) and new indication registrations. Maintain regulatory compliance for marketed products including product maintenance as manufacturing or labelling (Product Information and packaging) variations, renewals, pharmacovigilance activities, etc. Build partnership with officials in the Regulatory Authority and to keep updated on changes to local and global regulatory environment/trends and the impact of the regulatory requirements changes to the affiliate business opportunities.

Customers include all medical/marketing/business personnel within the affiliate, the Drug Regulatory Agency, and Area regulatory management

Primary Responsibilities:

1. Regulatory Planning

a) Regulatory Plan Development

i) Plan, review and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes.

ii) Manage and ensure Regulatory Plan for assigned countries is in alignment with Product Teams & Area strategies, and the country’s business plan.

b) Process Management

i) Coordinates the process with cross functional members of the affiliate, sites and corporate (Legal, Administration, etc.) to ensure timely availability of required documents and other requirements for dossier preparation.

ii) Active participation in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.

c) Regulatory Tools

i) Timely update of data in regulatory tools as per global process. Ensure that data is complete, accurate and communicated appropriately to relevant stakeholders.

2. Submissions and Approvals

a) Dossier Preparation

Prepare a quality regulatory dossier and submit within the planned affiliate timelines. Request and obtain the various regulatory items needed for submission. Prepare/format the dossier to ensure it meets regulatory requirements. Implement the submission and archive appropriately.

b) Gain Regulatory Approval

Gain Drug Regulatory Agency’s (DRA) approvals to meet the affiliate product launch plans and ensure product maintenance.

Activities include:

Provide quality responses to the Ministry of Health (MOH) by the due date Complete regulatory approval process and gain product licenses Communicate Product approval Archive submission dossier and approval documents Track post approval commitment, if any Perform regulatory responsibilities related packaging development Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs

c) Metrics Review

Prepare periodic Regulatory Report of actual submissions and approval and communicate to local management. Provide regulatory metrics on performance that are aligned with Area & IC Regulatory Affairs criteria to measure regulatory performance to Affiliate, Area & Regional management.

3. Regulatory Compliance

Compliance Maintenance Take appropriate actions to maintain all marketed products in compliance with regulatory and corporate requirements [eg. all aspects of labeling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that are registered with the DRA]. Conduct periodic compliance self-audit to identify potential compliance issues. Perform activities related to pharmacovigilance (PhV) according to Corporate and if applicable, by local regulations. Take corrective actions plans based on regulatory audit findings

b) Good Regulatory Practices (GRP)

Develop, update and implement appropriate SOPs as required