Lead - Corporate Affairs (Regulatory and Policy)

Division

Corporate Affairs

Department

Corporate Affairs

Sub Department 1

Job Purpose

• CDSCO Regulatory dossier review, submission and follow-up for timely approval and response submission.
• Strategize and coordinate with RA/IPD/Portfolio/Medical Affairs/Marketing team to obtain all the necessary approvals specific to products in compliance to regulatory requirement.
• Advocacy with external stakeholders/ regulators including DCGI, NPPA, DoP, ICMR, MOH etc.
• Advocacy on policy issues regarding pharma sector, effective engagement through industry associations (CII, FICCI, IPA, etc.). Relationship building at centre and state level positioning Cipla as a thought leader in the industry. Advocacy for pushing key policy / regulatory developments that support business growth opportunities. Proactively support brand building through positioning leadership team and promoting brand Cipla at key platforms.

Key Accountabilities (1/6)

Coordination with internal stakeholders for regulatory dossiers

• Active co-ordination with stakeholders for preparation of regulatory submission dossier as per DCGI requirement.
• Prioritizing the project and follow-up with internal stakeholder for early submission and approval.
• Ensure approvals for drug launches, Fixed Dose Combination (FDC) products.
• As per requirement, provide technical support to the FDA Liasioning Team related to Regulatory approvals

Collaborate effectively with internal stakeholders on regular basis

• Streamline processes with RA/ Portfolio/ Medical/ Clinical/ R&D/ FDA licensing Teams.
• Meeting approval timelines in accordance with Regulatory master plan.
• Drive toward full compliance with regulatory requirements for India.
• Zero Deficiency Submissions, to ensure the reduction of repeated queries and clearance of files smoothly.
• Analyse and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.
• Track, strategize, participate for DTAB/DCC/SEC/other relevant stakeholder meetings and share intelligence related to our projects/ company.

Key Accountabilities (2/6)

Engagement with external stakeholders

• Regular engagement with external stakeholders, key one being – DCGI, ICMR, DBT, NPPA, DoP, MOH among others.
• Strengthen and enhance advocacy with the external stakeholders. Ensure positive relations with the regulators and key government officials.
• Advocacy with regulators and government officials on Cipla projects/ regulations.

Policy Monitoring and Advocacy

• Regular policy tracking and monitoring developments
• Prepare Cipla recommendations with inputs from business and insights from industry associations.
• Lead advocacy efforts by share Cipla representation directly with government and through industry associations, Representing issues at relevant forums, meetings with government authorities.

Key Accountabilities (3/6)

Research, Communications, Advisory and Position Papers

• Share Advisory on issues of relevance - Drug developments, Budget, elections, parliament sessions, etc.
• Research and tracking of pharma / healthcare updates from relevant platforms including digital and social media
• Sharing relevant advisories on political, economic, pharma and healthcare related updates
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  Position papers and briefing documents for senior leadership on relevant issues and topics.

Regulatory pathway for timely registration of products in India

• Identifying the status of a product in India and globally.
• Strategize, review & analyse the proposed regulatory pathway for product approval.
• Review documents to avoid rejections/ minimise the queries from the regulatory authority.

Key Accountabilities (4/6)

Building Cipla Image and Thought Leadership by Engaging with Industry Associations and Think tanks

• Develop and maintain good connects with industry associations.
• Represent Cipla’s business and work extensively with Industry Groups and Associations, including providing inputs and direction to proactive/ reactive responses by Associations/ Chambers to Industry issues, policy development etc.
• Alignment with industry associations on industry issues; strategize and implement policy advocacy approach to ensure Cipla representation.
• Initiate programs and/or events that will contribute towards strengthening the overall image of Cipla as a thought leader within the industry.
• Identification of relevant key virtual forums and participation thereby for leadership and relevant stakeholders

Key Accountabilities (5/6)

Support Business and Cipla Foundation

• Work closely with different departments of the organization to understand stance of Cipla on various policies.
• Providing support on government engagement for business issues and proactive analysis of issues.
• Identifying opportunities with governments for collaboration.
• Support Cipla Foundation for CPC as and when requirsiness and Cipla Foundation

Key Accountabilities (6/6)

Update to Leadership and support on key priority areas

• Sharing important development / achievement from within Corporate Affairs.
•  Relevant leadership support as and when required (annual report, health reports, briefing books, external meetings, industry positioning).
•  Update on key priority areas - Respiratory, Wellness and AMR.
• Provide inputs around public communications on behalf of company, especially in cases of crisis.

Provide leadership to nurture the internal team

• Play an active role in team’s long-term development.
• Ensure that the team undergoes regular training to upskill their technical capabilities

Major Challenges

• Push for policies favouring Cipla amongst Govt. / relevant authorities
• Expanding network and strengthening relationships with governing bodies – at local, state and central level

Key Interactions (1/2)

• Corporate Affairs team – providing guidance and reviewing – frequent
• Head of Departments – providing guidance and inputs with a perspective on policies / external affairs – need based

Key Interactions (2/2)

• PMO, CMO, Central Government, Ministry of Health, DoP, NPPA, Commerce & Industry, Finance, Environment & Forest, Pharmaceuticals, External affairs– both central and state level – frequent – maintain good connects

Dimensions (1/2)

• Networking & impact created on policies
• Thought leadership and Cipla positioning

Key Decisions (1/2)

Advocacy for favorable govt. policies and regulations

Strategizing on policy recommendations

Key Decisions (2/2)

Policy inputs and submission to the government

Engagement strategy with external stakeholders

Education Qualification

B. Pharma /M. Pharma/ MBA with Experience in Regulatory / Policy domain

Relevant Work Experience

10-12 years of experience in Regulatory / Policy