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Remote Regulatory Strategist in Groton, CT at Apex Life Sciences

Date Posted: 11/15/2018

Job Snapshot

Job Description


Responsibilities

  • Collaborates with departmental and cross-functional colleagues (eg. GCMC, WSR, WRO and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.
  • Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.
  • Assuring product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
  • Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.
  • Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.
  • Leveraging both technical & regulatory knowledge to mitigate risks.
  • Delivery of high quality regulatory submissions.
  • Execution of regulatory policies and operational processes.
  • Execution and implementation of policies and operational processes.

Qualifications

  • Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
  • Developing effective relationships with local & global internal partners, i.e., PTx, PGS, WSR, etc.
  • Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Demonstrating ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
  • Execute training related activities (e.g. compliance-related, HR policies…),
  • Demonstrate & model adherence to all internal behaviors & values, embrace & comply with GCMC Principles of Integrity.
  • Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
  • Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
  • Demonstrating ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

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.




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