Manager/Sr. Manager, Regulatory Affairs
- RemeGen Biosciences, Inc.
- Rockville, MD Preferred - Open to Remote
- $150,000 - $180,000
- Start date
- Mar 20, 2023
- Clinical, Clinical Development, Medical Affairs, Regulatory, Legal/Compliance, Regulatory Affairs, Research/Documentation, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
RemeGen Biosciences focuses on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases. We leverage our deep insights into human biology, advanced protein engineering and design technologies, and rich experience in manufacturing and clinical development to uncover novel therapeutic targets and develop best-in-class and first-in-class biotherapeutics.
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. Draft 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. IND, BLA, or other FDA requirements.
- Communicate effectively with internal and external members of senior management, the project team, investigators, 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 inter-departmentally 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.
- 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.
- 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.
- Fluent in Mandarin and English.
Prolonged periods of sitting at a desk and working on a computer.
Full-time position in our MD office preferred, open to remote.
Candidate must be legally eligible to work in the US.
Remegen Biosciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
$150,000.00 - $180,000.00 per year
- 401(k) 401(k) matching
Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Professional development assistance Referral program Vision insurance
RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative biologics for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Inc., a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.
650 Gateway Blvd, Suite No. 110
South San Francisco
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