Senior Team Member - Regional RA

Posting Date: 11 Nov 2024

Department: Enabling Functions

Business Unit: Integrated Product Development

Country: India

State: Maharashtra

Location: Vikhroli

Req Id: 86366

Division

Department

Sub Department 1

Job Purpose

1.   Original Dossier review, compilation & submission.
2.   Product life cycle management (renewals, retentions, Variation submissions)
3.   Ensure timely product approval and ensure availability of compliant product for placing on market

Key Accountabilities (1/6)

Accountability Cluster	Major Activities / Tasks
I. Contribute to the regulatory strategy for CGA countries by participating in the team discussion and providing regulatory input as per the current guidelines during the initial phase of development till the submission of the dossier to ensure correct documentation and data generation	Provide the necessary information and the other preliminary details like the batch size details and the minimum packaging requirement to the cross functional team. provide RA input for requirements of CGA countries during product development phase Inform about the document requirement to the stake holders and providing necessary information on the newly published guidelines to the team Co-ordinate with the different department for multiple documents required &nbmplement chosen regulatory submission procedure which to ensure approval from agency within targeted timelines

Accountability Cluster

Major Activities / Tasks

I. Contribute to the regulatory strategy for CGA countries by participating in the team discussion and providing regulatory input as per the current guidelines during the initial phase of development till the submission of the dossier to ensure correct documentation and data generation

   Provide the necessary information and the other preliminary details like the batch size details and the minimum packaging requirement to the cross functional team.
   provide RA input for requirements of CGA countries during product development phase
   Inform about the document requirement to the stake holders and providing necessary information on the newly published guidelines to the team
   Co-ordinate with the different department for multiple documents required
&nbmplement chosen regulatory submission procedure which to ensure approval from agency within targeted timelines

Key Accountabilities (2/6)

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II. Review of the submission and associated documents as per the current regulatory requirement to ensure the correctness of the same for compliance with the regulatory health authorities requirement of filing

   Review and assist in preparing the dossier to ensure all the relevant documents are present in the dossier ensuring the completeness of the dossier which will ensure quick approval from the agency
   Review, compilation and submission of the dossiers for CGA core (WHO & USFDA).
   Module 1 preparation and finalization for Regulatory Health submission for CGA core + CGA countries.
   Monitor the document flow from Internal cross functional team and External Customers, to ensure that the timelines are met
   Track receipt of deficiency received from MOH and respond on the ceceived from Customer and internal stake holders to ensure that the dossier deficiency responses are submitted in time
   Track the product approvals and ensure it is received in the defined timeline.

III. Maintain the market authorisation throughout the product life cycle to ensure the compliance to product quality and safety and by renewing validity to ensure availability of the product in the market

   Evaluate the proposed changes to submitted dossier and proposals to post approval changes to determine/validate the appropriate category of change
   Review, compilation and submission of the variations for CGA core.
   Review, compilation and submission of the requalifications for CGA core.
   Module 1 preparation and finalization of variation packages
   &nbended dossier to ensure quick approval of variations from the MOH.
   Track and submit the product renewal dossiers within the validity expiry date for the applicable countries.
   Track and apply for the product retentions within the required timeline for the applicable countries.

Key Accountabilities (3/6)

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IV. Maintain the data base associated with the DOS by including all the details in the database for ease of product history

   Provide the status of the various products during the life cycle to the cross functional team as an when requested
   Maintain the regulatory database (Viz: PRC database & GPL)
   Follow regulatory SOPs.

V. Support Business, Internal cross functional team and External Customers wrt technical / regulatory aspects to ensure smooth supply and product serviceability

   Maintenance of RA tables in timely manner as per request from Business
   Provide required regulatory information to business for tenders & RFQs.
   Raise labelling change controls in timely manner.
VI Regulatory support to PV to meet pharmacovigilance requirements of the region
       Provide timely regulatory (Labelling) information to Global Drug Safety
   Provide timely product information to applicable stakeholders

Key Accountabilities (4/6)

IV. Maintain the data base associated with the DOS by including all the details in the database for ease of product history

   Provide the status of the various products during the life cycle to the cross functional team as an when requested
   Maintain the regulatory database (Viz: PRC database & GPL)
   Follow regulatory SOPs.

Key Accountabilities (5/6)

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V. Support Business, Internal cross

Communicate with external stakeholders, LTRs for ensuring the timely MOH submissions of dossiers, variations, renewals.
Continuous engagement with LTRs for dossier status updates, receiving the product approvals, variation approvals in time.

Key Accountabilities (6/6)

Major Challenges

   Change in business strategy leads to change in filing strategy, rework and in adherence to target deadlines
   Change in proposals affecting sections of the dossier informed during submission leads to change in filing strategy, rework and inadherence to target deadlines.
   Unavailability of documents from cross functional team leads to inadherence to target deadlines
   Processing of non-budgeted submissions lead to work imbalance
   Inefficient software support lead to inadher

Key Interactions (1/2)

Internal -

   Cross function teams (R & D, Unit, ADL ROC, CQA, CDT, LCM)- Data generation/amendment-Daily
   Business-Strategy-Adhoc
   Packaging-Data generation/amendment-Daily
   Clinical / Medical Writing -Data generation/amendment-Adhoc
   Planning /

Key Interactions (2/2)

External -

   Regulatory agency-Update, track Review comment, advise, seeking approval- Adhoc.
   LTRs - throughout submission and life cycle-Adhoc/Daily
   LTRs/MOH for GMP inspection related activities - Adhoc
   Supplier-Provision of data throughout submission a

Dimensions (1/2)

No. of countries 29
No. of Marketing Authorisations - 350
No. of customers - 14
No. of Regulatory agency - 2

Dimensions (2/2)

Key Decisions (1/2)

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Decisions	Recommendations
Classification and type of change amendments	Regulatory advise to cross functional teams in case of quality issues and deficiency responses to Group Leader regional
Regulatory strategy during stage gates
MA Submission strategy
Comments:

Key Decisions (2/2)

Education Qualification

Master of science

Relevant Work Experience

14 years of experience in the regulatory affairs department in a Cipla in the emerging market / SAGA region.