Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs (Oncology)
New Jersey - United States

We are seeking candidates to actively contribute and support the Regulatory Affairs activities to ensure all products comply and meet regulatory requirements. This new hire will be required to provide regulatory guidance on projects including regulatory strategy, requirements for clinical studies, marketing approval in both domestic and international markets, strategic development plans, and Health Authority interactions. Looking for an experienced regulatory affairs professional to work cross-functionally to represent the group; someone who brings positive and productive working relationships between team members and department representatives. Will have the opportunity to manage or mentor new employees and provide management support to ensure acceptable resourcing of projects.

• Lead assigned submission tasks with very little supervision to prepare routine correspondences, INDs/CTAs, BLAs/NDAs/MAAs, annual reports, IND/CTA amendments, orphan drug applications, etc.
• Lead & support Health Authority interactions with the following: briefing document prep, coordination of meetings, preparations with subject matter experts, and documentation of minutes.
• Support submissions of regulatory documentation including all work with CROs and partners to ensure timely submission.
• Participates in cross-functional sub-teams representing RA and promoting positive and productive working relationships between project team members and RA representatives.

Qualifications:

• B.S. degree in a scientific discipline required (Advanced degrees (MS, PharmD, PhD) preferred)
• With Bachelor's degree will need at least 7+ years of relevant industry experience (5+ years within Regulatory Affairs Strategy)
• With Master's degree, will need at least 4+ years of relevant industry experience (1+ years within Regulatory Affairs Strategy)
• Previous experience and strong knowledge of IND and NDA regulatory filings.
• Strong understanding and interpretation of GxP protocols and ICH, FDA, & EMA guidelines, and regulations to ensure compliance with requirements from healthy authorities.
• Experience with US and ex-US clinical trial submissions
• Working knowledge of US, EU, and ICH regulatory requirements.
• Experience within Oncology and/or Immunology therapeutic areas.
• Experience with CTD/eCTD preparations
• Strong interpersonal skills and the ability to work well and effectively with a variety of staff cross-functionally
• Demonstrate strong communication skills and organizational skills
• Experience with the interpretation of regulations, guidelines, policy statements
• Time management skills and the ability to work well independently
• Computer proficiencies with Microsoft Office Suites (Word, Excel, Visio) & Adobe Acrobat

If you meet the qualifications & interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com for more information.