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Senior Manager – Corporate Affairs (Regulatory and Policy

Posting Date:  25 Aug 2025
Department:  Corporate
Business Unit:  Corporate Affairs
Country:  India
State:  Delhi
Location:  Delhi
Req Id:  95279

Division

Department

Sub Department 1

Job Purpose

  1. CDSCO Regulatory dossier review, submission and follow-up for timely approval and response submission.

 

  1. 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.

 

  1. Advocacy with external stakeholders/ regulators including DCGI, NPPA, DoP, ICMR, MOH etc.
  2. 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.
    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.
    • Identification of relevant key virtual forums and participation thereby for leadership and relevant stakeholders.
    Initiate programs and/or events that will contribute towards strengthening the overall image of Cipla as a thought leader within the industry.

Key Accountabilities (5/6)

Support Bu

  • 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

Dimensions (2/2)

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

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