HomeMedical/Scientific Advisor/ConsultantAssociate Director - Corporate Affairs | Cipla Ltd | Delhi | 16.00-22.50...

Associate Director – Corporate Affairs | Cipla Ltd | Delhi | 16.00-22.50 L

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20000+ employees. 80 countries. Our secret of success, if you will, is something so simple, so pure and yet so powerful. It’s our Purpose- “Caring for Life”. It inspires us to find innovative solutions to patients’ unmet needs and forms the core of how we do business. It propels us to create value to the communities that we serve and we’ve been recognized aplenty for this.

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But what makes us truly smile? When our employees reach for the stars. And we do our bit to take them there-encouraging them to take up opportunities across our global offices, creating a challenging work environment and most importantly, standing by them, no matter what!  So, has our purpose begun to resonate with yours? Next step. Hit the button below!

Position: Associate Director – Corporate Affairs

Location: Delhi, India

Job Description:

 

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 requirements.
  • Advocacy with external stakeholders/ regulators including DCGI, NPPA, DoP, etc.

 

Accountabilities:

  • Identifying the current status of a product in India and globally
  • Strategize, review & analyze the proposed regulatory pathway for product approval.
  • Review documents to avoid rejections/minimize the queries from the regulatory authority.
  • Active coordination with stakeholders for preparation of regulatory submission dossier as per DCGI requirement.

  • Prioritizing the project and follow-up with internal stakeholders 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
  • Streamline processes with RA/ Portfolio/ Medical/ Clinical/ R&D/ FDA licensing Teams.
  • Meeting approval timelines in accordance with the 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.
  • Analyze and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.

  • Track, strategize, participate in DTAB/DCC/SEC/other relevant stakeholder meetings and share intelligence related to our projects/ company.
  • Regular engagement with external stakeholders, the key one being DCGI office, ICMR, DBT, NPPA, DoP among others
  • Strengthen and enhance advocacy with external stakeholders. Ensure positive relations with the regulators and key government officials.
  • Advocacy with regulators and government officials on Cipla projects/ regulations.
  • Coordination with internal team on pricing related notices and pricing approvals for new launch products.
  • Ensure timely NPPA related submissions and advocacy with the NPPA officials.
  • Support stem cell related products approval for Stemputics

Threshold skills and capabilities required to execute the role :

Technical knowledge of India Regulatory, dossier preparation review, co-ordination, inter-personal skills, good network at DCGI, FDA offices.

Qualification: B.Pharma/M.Pharma/Ph.D.

Experience: 10-15 Years

Salary: 16,00,000 TO 22,50,000 INR CTC/PA

Contact Details:

catherine.coelho@cipla.com

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