Connecting...

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9zy2lwcm8vanbnl2pvyl9kzwzhdwx0x2jhbm5lci5qcgcixv0

Director Regulatory Affairs

Director Regulatory Affairs

Job Title: Director Regulatory Affairs
Contract Type: Permanent
Location: California, USA
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: HQ00107477_1569864545
Contact Name: Isabella Wang
Contact Email: i.wang@sciproglobal.com
Job Published: September 30, 2019 18:29

Job Description

Director, Regulatory Affairs

United States - California


SciPro is a premier sourcing and advising agency that specializes in connecting highly-skilled life sciences professionals to robust business clients across the globe. Our client is looking for a Director of Regulatory Affairs in an exciting product-facing role in California.

Job Description

Director, Regulatory Affairs will provide regulatory leadership to support the development of new and current programs. This includes the implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance. This person represents the regulatory function on multi-disciplinary teams and will integrate company goals into the objectives and activities of the department. Global Regulatory Affairs is responsible for developing innovative global/regional regulatory strategies to advance novel medicinal oncology products for patients.


Responsibilities (include but are not limited to):

  • Develop and implement regulatory product strategies
  • Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, contingencies, and directives.
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
  • Lead and oversee activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
  • Plan, prepare, and review submissions to required authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projects
  • Represent the regulatory function on cross-functional development teams
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing programs
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
  • Serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams in global strategies and advise the US Regulatory Lead (USRL) in the development of applicable strategies and execution of filings
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and work with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
  • Coordinate and prepare responses to requests for information from regulatory authorities
  • Train, manage, and mentor other regulatory affairs personnel
  • Work externally to engage in regulatory policy initiatives
  • Other duties as assigned


Requirements:

  • PhD or PharmD in a scientific discipline preferred along with at least 8 years of experience in industry related Regulatory Affairs (or BS/MS with at least 10 years of relevant experience)
  • Knowledge and understanding of global regulations and guidelines
  • Previous experience in the preparation and submission of regulatory documents
  • Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
  • Experience with investigational drugs, including late stage development, and marketed products
  • Ability to work in a cross-functional team environment with experience managing people and project teams
  • Strong attention to detail and the ability to prioritize multiple tasks
  • Excellent organizational, computer and documentation skills and an ability to prioritize effectively
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment