Senior Dra Associate, Ksa

2 weeks ago

Riyadh, Ar Riyāḑ, Saudi Arabia Novartis Full time

Interactive and efficient coordination of the preparation and submission of the new registration dossiers and Life cycle maintenance files to ensure a timely Launch of new products, and smooth supply continuity of the registered products.

Full regulatory support to the Commercial team, Supply Chain, Marketing Department, Market access department and ERC to meet the TGT of assigned market(s).


  • Minimum 3 years' experience in the regulatory field (new submission/ maintenance activity/ pricing) in assigned market(s).
  • Review and compile the registration dossier in cooperation with the Regulatory Competence Centre (RCC) department and the local relevant stakeholders to fulfil the local requirements and ensure smooth and rapid submission and approval of the files, in a timely manner, in line with the registration planning cascaded by the DRA Head.
  • Review and Validation of the promotional and educational materials against health authority regulations and approved product information and obtaining the authority approvals when applicable.
  • Communicate the deficiency letters raised by the health authorities to DRA Head and relevant global stakeholders during evaluation within the specified timeframe.
  • Ensure supply continuity of the registered products by securing the timely submissions and approvals of the variations and requesting the renewals packages from global relevant stakeholders within a sufficient timeframe.
  • Maintain all market artworks in coordination with the labeling associate and manufacturing site in alignment with the country regulations and approved product information.
  • Ensure execution of Pharmacovigilance and patient safety regulatory activities in compliance with the relevant SOPs
  • Ensure that product patient information leaflets are updated according to the latest CDS update approved in the country of origin by securing timely submission in alignment with the relevant SOP.
  • Complete and regular archiving the registration files, authorities correspondence and relevant documents.
  • Monthly reporting of the activity, regular and accurate updating of the tracking tools.
  • Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued by the health authorities, and immediate gap assessment and timely implementation within the company when applicable.
  • Regulatory Support for the local supportive functions including but not limited to: business development, market access, supply chain management and medical.
  • Participate in local procedural documents and SOPs development and maintenance.
  • Ownership and participation of coaching of regulatory team new joiners and onboarding of local teams new joiners.

Commitment to Diversity & Inclusion:

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements
Language - Fluent Arabic and English.

Education :

  • Pharmacy degree

Experience:
Minimum 3 years

Division

SANDOZ

Business Unit
Commercial OPS SIR SZ

Country
Saudi Arabia

Work Location
Riyadh

Company/Legal Entity
Sandoz Pharmaceuticals d.d.

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
Yes

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