Associate Director, Regulatory Affairs
Regulatory Professionals, a division of Premier Research (a mid-sized Global CRO), is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world.
With a presence in the US, EU, Canada, Asia Pacific we are looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.
Working at Regulatory Professionals means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Regulatory Professionals is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic Associate Director, Regulatory Affairs to join our team. This job will be based in Shang Hai, China.
The role will be home based and full/part time/flexible working patterns can be considered.
You will be the first Regulatory Affairs employee in Shanghai, China - this is an exciting role where your responsibilities will be varied and you will have the opportunity to truly make an impact! We are really focused on identifying a candidate who can demonstrate global regulatory experience or exposure.
To be considered you must be able to advise on marketing strategies and have experience supporting global strategies that incorporate China.
You will be an expert Regulatory professional, confident at talking strategy with prospects and able to demonstrate and understanding of both local and US requirements from a Regulatory perspective.
You'll be accountable to:
- Develop and execute China regional strategies and contingencies for assigned projects by analyzing situations or data that require an in-depth knowledge of organizational objectives.
- Lead specific pieces of work and may be the Regulatory Submissions lead for projects, using broad expertise, unique knowledge and skills to contribute to the development and achievement of organizational goals.
- Prepare study documentation for filing to China Regulatory Authorities (IND, HGRAC, PFDA, import and export license applications
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
- Interfaces with other departments to design cross-functional process efficiencies or develops new approaches to the clinical management and monitoring of clinical trials considering Phase I - IV paradigms
- Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to assigned product/project areas.
- Ensure compliance to Local Government policies and local Regulatory bodies
- Participate in project development and regulatory strategy planning sessions. Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues.
- Creates formal networks both within and outside the organization to build relationships with Regulators and manage meetings with Regulatory Agencies.
- May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative.
- Work closely with Country and global sales to promote Premier Research capabilities to local and global customers.
- Analyzes situations or data that requires significant evaluation of intangibles, independent judgment in methods, techniques and evaluation criteria for obtaining results.
- Support business development related activities including bid defense presentations, assisting with client request for proposals, and sales strategy calls.
- Write and/or review a complete single service regulatory proposal and defend costs and timelines to clients.
- Line management, mentoring and guiding of junior staffs as the team grows (this will not be immediately)
- Think ‘analytically and strategically’ and convey complex concepts in an understandable manner
- Work on special regulatory projects as assigned.
You'll need this to be considered:
- Bachelor’s degree, or international equivalent from an accredited institution, in a Life Sciences field
- Extensive and proven experience in the pharmaceutical, biotechnology or Regulatory Affairs or Drug Development in China, CRO experience is preferred
- Demonstrated experience interacting with the NMPA required, experience with other regulatory agencies preferred
- Demonstrated experience in the establishment of clinical trial applications and supporting approvals of Marketing Applications
- Business development and experience in attending bid defenses is preferred
- Results driven and team-oriented, with the ability to influence outcomes as necessary
- Able to innovate, analyze, and solve problems with minimal supervision
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
- Exceptionally keen attention to detail
- Able to develop and implement creative approaches to ensure regulatory success