Manager/Director of Regulatory Affairs – #1479

Therapeutic Area:       Immuno-Oncology/Oncology
Location:                      Fully Remote with a Maryland HQ
Position Status: Full-time and permanent

*We offer a $1000 reward for successful referrals.  See additional information below.

Company

Our client company is a well-established clinical-stage T-cell-focused biopharmaceutical company. Their leading drug candidate is uniquely positioned to address key unmet medical needs in immune-oncology and other diseases.   They are partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics and to rapidly expand into additional combinations such as CAR-T.   They are well established and rapidly expanding.

POSITION SUMMARY

The Regulatory Affairs (RA) Manager/Director ensures that all non-clinical and clinical development programs at the Company meet relevant guidelines, standards, and regulations. This position will be working with both the Translational Research Division and Clinical Division as well as with the partner CROs directly to ensure compliance and inform the Company of any updates to regulations. This position will also be responsible for developing the non-clinical/clinical regulatory strategy for the Company’s target markets such as US, EU, and LATAM in accordance with each country’s regulatory requirements to enhance the probability of regulatory success and regulatory compliance and being the main liaison with regulatory agencies as a representative of the Company.

Responsibilities

  • Develops regulatory strategies for individual programs in nonclinical/clinical development towards the goal of successful registration in the Company’s target markets such as US, EU, and LATAM
  • Provides non-clinical/clinical regulatory guidance and updates to the relevant division(s)
  • Manages CROs in preparing regulatory documents for submission including:
    • CTD-Modules 2.4, 2.5, 2.6, 2.7, 4, and 5 regulatory writing and/or review
    • US-IND documents
    • EU-CTA documents (e.g., IMPD-nonclinical/clinical part)
    • USFDA Formal meeting package (e.g., meeting request form, meeting package on nonclinical/clinical questions, company positions, and meeting minutes
    • EMA Scientific Advice meeting package (e.g., letter of intent, briefing documents on non- clinical/clinical questions and company positions)
  • Compiles and maintains appropriate regulatory documents for submission
  • Provides regulatory approvability assessments for the relevant indications
  • Manages timelines for non-clinical/clinical documents’ deliverables and regulatory submissions
  • Leads regular internal and CRO meetings for status and tracking updates, issue resolution, project  monitoring, and escalating issues to key stakeholders
  • Ensures that all non-clinical and clinical programs and data are compliant
  • Leads communication with regulatory authorities regarding meetings and submissions including orphan drug designation, IND filing/amendment, CTA filing/amendment, USFDA formal meeting, EU-NCA SA meeting, EMA-SA meeting, annual report, drug safety update report, etc.
  • Prepares and supports efforts for pre-approval of GCP Inspection from regulatory authorities
  • Responsible for life cycle management in all concerned countries
  • Provides leadership and guidance to team members including coaching and performance evaluations

Qualifications/Experience/Education

  • Bachelor’s degree in a life science required; Master’s degree or PhD preferred (flexible)
  • 5+ years experience (will depend on the level of position offered) in clinical development, clinical operations, and/or regulatory affairs
  • Related experience working in oncology or immuno-oncology therapeutics (not a requirement)
  • Experience leading, managing, and preparing CTD & eCTD regulatory submissions
  • Working knowledge of ICH, GCP, and FDA and EMA guidelines/regulations
  • Understands the drug development process with a special emphasis on regulatory requirements at each development stage for nonclinical and clinical at EMA as well as USFDA
  • Approximately 30% travel may be required (not applicable during the COVID-19 pandemic)

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HAVE INTEREST OR QUESTIONS? Next step options include:

*Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

Want to make a referral?
Do you want to make a referral for this position or our recruiting services?  We offer a $1000 reward for each successful referral.   There are two ways to make a referral:

  • Email us and provide contact information for the person you would like us to reach out to.  Your name will not be revealed without our receiving your approval in advance.
  • Provide our information (i.e. name, website, email address) to the person whom you feel may have an interest.   Please ask that person to mention your name when they contact us.​

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Disclaimer:  This is an unofficial document prepared by OncologySearch.com to provide basic information concerning the position.   The company we are conducting this search for has the official job description.