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Associate Director, Regulatory Affairs

Cambridge, MA

Posted: 10/07/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2444

Our client is searching for a creative, resourceful, integrative thinker for a role that is responsible for regulatory activities related to the company’ s clinical development programs.

Responsibilities:
  • Develop regulatory strategy and submission plans for quality and timely filings.
  • As a member of study teams, provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development, registration, and post marketing activities of pharmaceuticals.
  • Compile, review, approve and submit clinical trial (e.g. IND, CTA), marketing registration (e.g. NDA, MAA), and post marketing applications, amendments, and supplements.
  • Prepare regulatory agency meeting requests and briefing documents.
  • Develop and provide strategic guidance for pediatric submissions (e.g. PSP, PPSR, PIP)
  • Assist or lead in activities related to approved product labeling and Risk Evaluation and Mitigation Strategy (REMS)
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Support the organization and record regulatory meetings with health authorities.
  • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority, Expanded Access) or special status (e.g. Orphan).
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.
  • Assist with SOP generation.
  • Perform other duties as required, interfacing with other departments, CROs and external vendors as needed

Requirements/Qualifications:
  • Bachelor of Science in a scientific discipline; Master’ s degree in a scientific or management discipline preferred
  • 5+ years of experience in Regulatory Affairs related to development of investigational pharmaceuticals (Phase 1 through Phase 3)
  • eCTD elements and structure experience 
  • Additional experience with marketing registration applications, post marketing activities (e.g. labeling, safety reporting), and pediatric development preferred
  • Possess strong written and verbal communication skills, including advanced regulatory writing skills
  • Advanced knowledge of the Microsoft suite of tools including Word, PowerPoint, etc.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
  • Demonstrated ability to operationalize complex regulatory strategies. Ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Kelley Cole
Clinical Recruiter

Kelley brings 5 years of experience in full life-cycle recruitment and talent acquisition management, along with a strong client services background, to her role as Clinical Recruiter for The Steely Group. A desire to make a difference and add positivity to this world are two factors that influenced Kelley’s decision to become a recruiter. “Connecting a candidate with a better opportunity that could have a huge impact on them and their family is very fulfilling,” she says.

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