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AD/Sr. Manager, Regulatory Affairs

Parsippany, NJ

Posted: 08/02/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2383

Our client – a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients – is looking to add a Regulatory Affairs Manager to their team on a permanent basis. The purpose of this position is to provide expertise and leadership for Regulatory projects focused on clinical development. The Regulatory Affairs Manager will be a lead internal resource for information and guidance regarding the maintenance of INDs NDAs and ex-US applications, support for ongoing Phase 3 clinical trials, preparation and submission of regulatory submissions, and other regulatory affairs responsibilities.

Responsibilities include:
  • Participate as the Regulatory Affairs representative on assigned project; project manage development teams and provide current regulatory information and guidance on a proactive basis.
  • Lead or support regulatory projects focused on clinical development; work closely with all functional areas of the company to provide guidance and support on regulatory matters.
  • Support management of internal resources for information and guidance regarding the maintenance of INDs and NDAs, support for ongoing clinical studies, and the preparation and submission of regulatory application documents.
  • Lead or provide support for preparation of regulatory filings for submission to US and international health agencies in the areas of new drug development marketing applications, and approved product support. This includes annual reports, IND or other clinical-trial applications, meeting requests, and health-authority commitments.
  • Support development of regulatory strategies and identification/implementation of appropriate submission strategies for assigned projects.
  • Ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and procedures.
  • Manage or co-manage regulatory projects including overall strategy, resources, costs, time and vendors, and ensure that project work proceeds according to agreed deadlines.
  • Proactively identifies and addresses complex problems; proposes solutions and assists in developing solutions.
  • Monitor and maintain awareness of regulatory environment assessing impact to business; interprets and disseminates regulatory intelligence information to appropriate stakeholders.

Requirements / Qualifications:
  • Bachelor’ s degree in an Analytical Science (biological sciences, chemistry, physics, engineering, pharmacy, or equivalent) from an accredited college or university; advanced degree preferred.
  • Minimum 4 years relevant experience in Regulatory Affairs with a focus on the clinical development of pharmaceutical projects, or equivalent experience.
  • Demonstrated knowledge of regulatory requirements with the ability to interpret and apply regulations to specific projects (IND, NDA, GCP, ICH and other regulatory guidance requirements).
  • Ability to manage multiple responsibilities with a high degree of self-motivation and ability to work independently.
  • Strong organizational skills, negotiating, and problem solving skills.
  • Excellent written and oral English communication skills.
  • Proven ability to interact successfully with all levels of the organization.
  • Demonstrated public speaking skills.
  • Proven time/project management skills.
  • Proficiency in Microsoft Office including Word, Excel, and PowerPoint.

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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