Job Description

Global Regulatory Manager
Job Number: 21-01795
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Global Regulatory Manager for our client in Lawrence Township, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
  • Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
  • Provide operational support on strategic regulatory documents to help drive timely deliverables
  • Drive operational excellence in Global Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency
  • Additional responsibilities, in conjunction with regional and/or global regulatory leads, include:
    • IND, BLA, and NDA maintenance submissions
    • Safety and Annual report submissions (regulatory components)
    • Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of response to HA queries according to the rapid response process.
    • Maintaining global submission plans and supporting those plans can be executed on time
    • Coordinating and driving global regulatory subteam meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with Subteam members to uphold accountabilities and drive decision-making
 
Qualifications:
  • Solid scientific background (BS, MS, PhD, PharmD)
  • 1-3 years of pharmaceutical industry experience or related healthcare fields. Ideally 1 year in regulatory affairs or 1-2 years in a complementary functional area (eg, clinical research)
  • Demonstrates a high-level of self-motivation and professional commitment. Indirect management experience of people or major projects
  • Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills
  • Excellent communication skills
  • Comprehensive understanding of the pharmaceutical industry
  • Comfortable working in a fast-paced environment where speed is paramount
  • Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions
  • Willingness and ability to effectively work in a highly matrixed team environment
  • Develop understanding of different TAs due to assignment to different projects
  • Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape
  • Increased exposure to global and multi-functional teams
  • Strong team player with ability to seamlessly collaborate across functional and geographic boundaries to achieve company’s goals
  • Strong attention to detail
  • Thrives on seeking and incorporating constructive feedback
  • Communicates opinions, facts and thoughts with clarity, transparency and honesty
  • Demonstrates ownership of results within (and beyond) area of responsibility
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved
  • Looks for opportunities for continuous improvement
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | LinkedIn
 
Equal Opportunity Employer:
Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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