Senior Regulatory Affairs Manager
Company: RemeGen Biosciences, Inc.
Location: Rockville
Posted on: June 20, 2022
Job Description:
The Regulatory Affairs Manager is the primary point of contact
and is responsible for facilitating integrated delivery, oversight,
and management of all phases of IND life cycle. The goal is to
ensure optimal IND or BLA preparation, including overseeing project
scope, managing process with multiple function teams, and meeting
key timelines and milestones.
KEY DUTIES AND RESPONSIBILITIES:
- Representing the company in formal meetings with the FDA and
EMA
- Overall project management from project kick-off through IND or
BLA preparation/other regulatory submission for FDA, ensuring that
the project objectives have been met
- Direct IND and NDA coordination and preparation
- Edit regulatory document, and ensure compliance with FDA
regulations guideline for Good Clinical Practice (ICH-GCP), and
Standard Operating Procedures (SOPs) for projects filed under a
U.S. Investigational New Drug (IND), BLA, or other FDA
requirements
- Communicate effectively with internal and external members of
senior management, the project team, investigators and site
personnel, and expert physicians
- Lead the development, implementation and review of the
Project-Specific Plans
- Manage problem identification and resolution in order to adhere
to the project timelines and budget
- Recommend outsourcing when appropriate and interact with
appropriate project team members to ensure that outsourcing to
Contract Research Organizations (CROs)/vendors will meet expected
performance standards for quality, timeliness and budget
- Supervise the planning and facilitation of investigator
meetings
- Participate in bid defense presentations and meetings
- Collaborate interdepartmentally on the proposal development
process
- Other duties as assigned
REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree (or equivalent) in life science, biological
science, clinical research or any other healthcare field and 5
years of experience with regulatory affairs in pharmaceutical or
biotechnology firm. - OR Advanced degree (MS, MD, PharmD, PhD,
etc.) in life science discipline, biological science, clinical
research or any other healthcare field and 3 years of experience
with regulatory affairs pharmaceutical or biotechnology firm
- Working knowledge of FDA regulatory requirements for IND and
BLA.
- Extensive understanding of eCTD modules, regulations, clinical
research principles and drug development processes
- Ability to write regulatory modules in eCTD system, and to
manage overall project scope and timelines using appropriate skills
(e.g. need be familiar with Gannt plots for PM)
- Ability to drive projects to completion by proactively
coordinating the efforts of external and internal partners or
CROs
- Strong written and verbal communication skills
- Dynamic individual with ability to lead, organize and motivate
team members
- Ability to work effectively both independently and in a team
environment
- Strong organizational and planning skills
- Excellent interpersonal and professional skills
- Excellent time management skills with the ability to prioritize
responsibilities and multitask
- Self-motivated and detail oriented
- Proficient in Microsoft Office and able to learn appropriate
software
Keywords: RemeGen Biosciences, Inc., Rockville , Senior Regulatory Affairs Manager, Executive , Rockville, Maryland
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