Regulatory Affairs Coordinator - Bilingual Spanish/English (JP4325)

Location: Thousand Oaks, CA
Date Posted: 05-31-2018

Job Title: Regulatory Affairs Coordinator (JP4325)
Location: Thousand Oaks, CA
Employment Type:  Contract
Business Unit:   Intercontinental – Latin America
Duration:  1+ years (likely extensions)
Rate: $20 - $21/hour

3Key Consulting Inc. is looking for role for a bilingual (English/Spanish) Senior Associate Regulatory Affairs with 2 – 3 years’ experience or Masters degree in Regulatory Sciences and no experience in regulatory submissions for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
3 Key is looking for the ideal candidate to support our client with the execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Must be Bi-lingual English/Spanish- both written and verbal.
  • BS or MS in Health Sciences (Biotechnology, Chemistry, Biology, Biochemistry, Pharmacy or similar).
  • Manager would also look at recent grad or someone completing MS in regularly with no industry experience if bi-lingual and right type or person.
  • Cross functional role-will be collaborating , QC labeling documentation, complaining and submitting submissions and compiling data and archiving in a highly regulated documents.
The Regulatory Affairs Coordinator will be responsible for:
  • Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Management and execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
  • Coordination and execution of Regulatory Affairs processes and deliverables.
 
Top Must-Have
  • Good communication skills (both oral and written) within a technical and clinical environment (Fluent in both English and Spanish: high level command on written, reading and speaking skills).
  • Action orientated with ability to manage multiple activities.
  • Document management and archiving practices with high attention to detail
 
Day to Day Responsibilities:
  • Ensure regulatory submissions are completed on time and meet Amgen’s corporate and local regulatory requirements, as applicable.
  • Contribute to and execute the filing plan for assigned products and countries, as applicable.
  • Develop and Review source text for country labeling.
  • Disseminate relevant information to team(s), as appropriate.
  • Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams and provide advice on local regulatory considerations in a timely manner.
  • Coordinate and QC translations of technical documentation (CMC, clinical and legal) for local regulatory submission.
 
Why This Position Is Open:
Supplement additional workload on team related to new footprint in Latin distributor markets.
 
Employee Value Proposition:
Working regionally with Latin Americas which is not normal opportunity to work internationally. Amgen is the largest Bio tech company in industry. To be part of a cross functional team working with Regulatory, Supply Chain, Quality, and commercial.
 
Red Flags:

 
  • Applicant must be fluent in both English and Spanish (high level command on written, reading and speaking skills).
  • Applicant must poses a professional background in Health Sciences (Biotechnology, Chemistry, Biology, Biochemistry, Pharmacy or similar).
 
Interview process:
Three interview rounds: 1. Interview with hiring Manager (In-Person preferable) 2. Panel interview with Working Team composed by 3 people (In-Person preferable) 3. Interview with Department Director (Phone or In-Person).
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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