Associate  Regulatory Affairs- Bilingual (JP4523)

Location: Thousand Oaks, CA
Date Posted: 07-19-2018
Job Title: Associate  Regulatory Affairs-Bilingual  (JP4523)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
Business Unit: Intercontinental - Latin America
 
3Key Consulting is looking for an Associate  Regulatory Affairs for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
 
JOB SUMMARY:
 
Onsite M-F normal core working hours. 

Ideal candidate- 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 SKILL SETS:
1. 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)
2. Action orientated with ability to manage multiple activities.
3. 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)

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We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
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Regards,
 
3KC Talent Acquisition Team
 
 
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