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Seçili özgeçmişindeki bilgilerle bu ilanın kriterlerleri sadece %30 uyumlu.

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Seçili özgeçmişindeki bilgilerle bu ilanın kriterlerleri sadece %30 uyumlu.

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Diğer Bilgiler

QUALIFICATIONS AND JOB DESCRIPTION

Regulatory Associate (Temporary - Seniority Opportunity)


RESPONSIBILITIES 


Perform local regulatory affairs activities on a day to day basis under supervision by:

  • Obtaining and maintaining product licenses for marketing affiliate by preparing and filing submissions to local regulatory agency, e.g. new products, line extensions, variations (Chemistry, Manufacturing and Control (CM&C), new indications, labelling etc.), renewals, co-marketing and GMP submissions for the inspections.
  • Supporting responses and issue resolution with regulators
  • Using and updating corporate regulatory systems e.g. RAPT (Regulatory Activity Planning and Tracking) and RRIC (Regulatory Requirements in Intercontinental Region) as applicable
  • Maintaining complete archive of all MoH communications and all submitted and proposed documents (product dossier, etc.)
 
Contribute to the successful implementation of local commercial objectives by:


  • Beginning to establish relationship with junior officials in the local regulatory agency (via direct interactions or industry associations)
  • Building and maintaining relationships with Medical and Marketing in the affiliate to facilitate submissions and timely update of labeling materials (as appropriate). Gaining support for solutions to standard or small scale issues
  • Responding to queries on regulatory processes and regulatory status
  • Analyzing possible solutions to solve a range of regulatory problems
  • Becoming knowledgeable on all aspects of regulatory affairs and aware of national legislation and guidance as well as some areas of the latest regional legislation and/or ICH guidance if applicable
  • Using appropriate local and global SOPs as required by the Safety and Efficacy Quality System (SEQS) and the applicable Lilly Quality Standards.
 
Act as ALRP delegate:

  • Performing Affiliate Product Information (API) and Affiliate Drug Information (ADI) labeling tasks such as development of new packaging material, maintaining existing packaging material updated in compliance with Core Labeling and local regulatory requirements and approving packaging material through BLUE system for the products under responsibility.
  • Collaboration with GOLD regarding safety and CDS compliance.
  • Submitting API labeling changes in due time per instructions communicated by SAIL
  • Maintaining records of locally submitted and approved labeling documents and packaging components.
 
REQUIREMENTS

 
  • Relevant scientific degree or Bachelor's degree in pharmacy or life sciences (pharmaceutical, medical, chemical) is required
  • Minimum 2-5 years of experience in a similar job
  • Good command of English - written and verbal
  • Very good knowledge of MS Office applications
  • Effective communication skills to interact with diverse groups and individuals
  • Strong decision-making and problem-solving skills to impact own priorities and allocation of time to meet deadlines
  • Foundational knowledge and understanding of local and global regulatory procedures as well as European ones as applicable
  • Strong knowledge of quality systems is an asset

PREFERRED CANDIDATE

POSITION INFORMATION