Manager/Sr. Manager-Regulatory Affairs

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 countryu2019s 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 Agencyu2019s (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 by the Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices. Complete Global and/or IC Regulatory Core Curriculum and Good Regulatory Practices training

4. Regulatory Influence

External

Regulatory Customer Relations

Establish relationship with key regulatory officials (throughout direct interactions, industry associations, etc.) to influence regulators to foster positive regulatory environment for business and research.

Regulatory Environment Changes

Keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties.

Influence Strategy

Supports in developing and implemeting external regulations and influence strategies

Internal

a) Affiliate Organisation

Learn and understand the local affiliate organization and functions. Build functional partnership and credibility to maximize regulatory value in support of business decisions. Recognized as a valued member of affiliate decision making process that has or potentially has regulatory involvement

b) Regulatory Value

Proactive use of regulatory tools (RAPT, RRIC etc.) to communicate affiliate business partners of the global regulatory status of new products and local regulatory trends that may impact the business. Educate the affiliate the value that the regulatory function can significantly contribute to the business.

5. Additional Responsibilities (if applicable)

Technically supports with Health Economic data for Drug Regulatory Agency price negotiations. Provide quality regulatory support for locally manufactured products Provide regulatory support for locally performed clinical trials (i.e. gain CT approval, CT material labelling, CT licence, etc.) Perform below responsibilities of ALRP/ Alternate ALRP/ Delegate ALRP as assigned:

a.Affiliate product information complies with regional and local regulatory requirements the updated Affiliate product information is submitted to the local MOH within the designated timelines

Update RAPT and relevant tools with the dates of regulatory submission, approval and internal approvals etc. Ensure that data is complete, accurate and communicated appropriately to relevant stakeholders

c.The appropriate printed packaging development (PPD) site and packaging operation are identified and notified of the date of regulatory approval/acceptance and designated timing for implementation of the updated Affiliate Product Information Affiliate Product Information for marketed products is maintained

d.Proposed and approved truth copies are kept under version control

e.Proposed and approved truth copies/ Truth packages are complete and accurate prior to submission to PPD

f.Agreements with local MOHs regarding submitted label changes are documented and communicated to GoLD

g.The appropriate Quality unit is notified of labeling errors to determine if labeling assessment report should be completed or not.

Minimum Qualification Requirements: u00A0

B.Pharm, M. Pharm, BSc or Masteru2019s Degree in Chemistry or Biotechnology or related areas, or MD (licensed in the country, if applicable, according to local regulations). Minimum 3 years of regulatory affairs or related experience In-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical products and devices and understand its interpretation as well as Regulatory Corporate policies Have or acquire overall understanding of the local business decision-making process that impacts the regulatory strategy.

Other Information/Additional Preferences:

Good knowledge of written and spoken English. Additional languages beneficial Broad understanding of what is needed to achieve results within regulatory Broad understanding of Lillyu2019s goals and objectives Competent project management skills Ability to handle multi-task activities Good oral/written communication & interpersonal skills Ability to handle conflict initiative and negotiation skills Analytical skills: accuracy, reliability Creative thinking and problem solving Customer Focus

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