Regulatory Affairs Manager

Regulatory Affairs Manager
Empresa:

(Confidencial)


Lugar:

Bogotá D. C.


Área:

Otros

Regulatory Affairs Manager

Detalles de la oferta

1 million patients will be impacted by our Regulatory Affair Manager role based in Bogota. As part of the longer-term strategic plan and investment of Sandoz though Biosilimilars, this is an opportunity to bring a biosimilar and high quality generics products to those in need.

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Ensures a controlled documentation system, record retention,
and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

Minimum requirements

Relationship Management Working experience within the pharmaceutical industry Regulatory Submissions Spanish Regulatory Strategy Regulations & Guidelines Health Authorities Regulatory Submissions Pharmaceutical and at least 8 yeas of experience in regulatory affairs

Relationship Management Working experience within the pharmaceutical industry Regulatory Submissions Spanish Regulatory Strategy Regulations & Guidelines Health Authorities Regulatory Submissions Pharmaceutical and at least 8 yeas of experience in regulatory affairs

Division

SANDOZ

Business Unit

COMMERCIAL OPS LATAM SZ

Country

Colombia

Work Location

Bogotá D.C

Company/Legal Entity

NOV COL

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No


Fuente: Kitempleo


Área:

Requisitos


Conocimientos:

  • Access

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