[Close] 

Regulatory Specialist


Apex Life Sciences is searching for a qualified Regulatory Specialist to work at an exciting pharma company in the greater LA area!


RESPONSIBILITIES




  • Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions and operational activities. This position will support electronic submissions for a growing regulatory team.


  • Support the day-to-day regulatory operational functions including the planning and management of Regulatory Operations resources to support timely and quality submissions to regulatory authorities


  • Maintains awareness of regulatory formatting requirements, evaluates potential impact to company; recommends updates to internal guidance, templates and training documents


  • Formats daily regulatory submission documents ensuring that documentation meets company?s submission-ready standards under limited supervision


  • Demonstrates expertise and provides technical assistance for formatting regulatory submissions verifying and applying appropriate formatting


  • Formats MS Word documents by applying appropriate styles and formatting techniques to text


  • Formats PDF documents in Adobe Acrobat


  • Responsible for quality of documentation formatted for electronic or paper-based submissions


  • Assists with updating formatting processes (WINs) and SOPs


  • Oversee paper and electronic submissions, communicating with regulatory operations vendors. Provide electronic document management coordination and services


  • Provide business user support for the workflow of submission documents through the document management system and PleaseReview


  • Maintain regulatory templates by facilitating template updates.


  • Provides system metadata clean-up support as necessary.



SKILLS AND ABILITIES




  • Attention to detail, organized and ability to support multiple projects at the same time


  • Excellent written and verbal communication skills including the ability to communicate effectively with internal colleagues at various levels, and with external vendor partners


  • Strong negotiation and collaboration skills?


  • Knowledge of applicable regulations?


  • Technical system skills (e.g. Veeva, Adobe Acrobat, MS Word, PleaseReview)?


  • Knowledge of MS Word Templates, Their Function and Use, MS Word Macros?


  • Adobe Acrobat Expert


  • Working knowledge of Adobe Acrobat PDF formatting, advanced features such as OCR & Bookmarking


  • Working knowledge of ICH Submission Readiness Standards?


  • Ability to work under deadlines?


  • Ability to identify compliance risks and resolve or escalate when necessary?


  • Work independently with minimal direct supervision?


  • A problem solver and critical thinker that relies on own judgment for the appropriate level of decision making


  • Knowledge of Regulatory guidelines such as IDMP, US FDA, EU, ICH, GCP, GMP, and ISO.



Education and Professional Experience




  • Minimum of a bachelor?s degree, preferably in Life Sciences/Health Related Sciences, from an accredited college or university


  • 5 years of related pharmaceutical or biopharmaceutical industry experience, with at least 3 of those years directly in Regulatory Operations


  • 3+years of user experience within an Enterprise Document Management System is desired


  • Knowledge of regulatory requirements


  • Proficient in pertinent software & tools


  • Knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD)



EEO Employer


Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.


 

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Regulatory Specialist (Document Control - CMC ...
San Diego, CA Apex Life Sciences
Sr. Regulatory Specialist & Manager
Redwood City, CA The HT Group
Principal Regulatory Specialist
Sunnyvale, CA Cepheid
Regulatory Specialist
Folsom, CA HDR, Inc.
Regulatory Specialist
Walnut Creek, CA HDR, Inc.