Team Lead – Corporate Affairs (DCGI submissions and Approvals)

Division

Department

Sub Department 1

Job Purpose

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

2. 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.
3. Advocacy with external stakeholders/ regulators including DCGI, NPPA, DoP etc.

Key Accountabilities (1/6)

Regulatory pathway for timely registration of products in India

• Identifying the current 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 (2/6)

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

Key Accountabilities (3/6)

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 (4/6)

Engagement with external stakeholders

• Regular engagement with external stakeholders, key one being – DCGI office, ICMR, DBT, NPPA, DoP 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.

Key Accountabilities (5/6)

NPPA and Pricing related notices & new pricing approvals.

• 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. 

Key Accountabilities (6/6)

Stempeutics

Support stem cell related products approval for Stempeutics

Major Challenges

• Actively co-ordinating with different internal stakeholder for ensuring dossier submission as per DCGI requirement.
• Ensuring on-time / before-time approval.

Key Interactions (1/2)

Regulatory, IPD, Portfolio, Medical Affairs, Clinical, Supply Chain, Corporate QA, Packaging, India Business

Key Interactions (2/2)

DCGI, NPPA, DoP, DGHS, DBT, CSIR, ICMR

Dimensions (1/2)

Dimensions (2/2)

Key Decisions (1/2)

Decisions pertaining to Dossier review and submissions at DCGI office, internal coordination, pathway for key projects, advocacy with regulatory bodies

Key Decisions (2/2)

Recommendations on approval pathway, reduction of timelines, projects which are getting delayed/held up, any new project to be considered, streamlining processes

Education Qualification

B. Pharm/ M.Pharm/PhD

Relevant Work Experience

12-15 years of experience in India Regulatory Affairs