Senior Regulatory Associate (Taiwan) REMOTE

工作内容

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.As our organisation continues to grow we are delighted to be expanding our business in Asia Pacific and are now looking for a Senior Regulatory Associate to be located in Taiwan. This position can be offered fully remote.As a Senior Regulatory Associate, you will assume regulatory responsibilities including initial and subsequent Clinical Trial submissions to national Regulatory Authority (RA) and Institutional Review Boards (IRB) in their assigned country(ies) and ensure compliance with local, regional, and international clinical trials regulations and guidelines. May further function as Regional Regulatory Lead for their geographic region.Essential functions of the job include but are not limited to:

• Provide support to Global/Regional Regulatory Lead(s) for assigned countries and studies and may on occasion be requested to function as Regional Regulatory Lead.
• Preparation of Investigational New Drug (IND) applications to national Regulatory Authority(ies) for assigned countries
• Preparation of submission dossiers (initial and amendments/notifications) for submission to RA, IRB, and other applicable local review bodies according to local requirements and within required timelines to obtain all necessary authorisations/approvals for the conduct of the Clinical Trial.
• Regulatory review of documentation to ensure compliance with national, regional and/or international requirements
• Interaction with RA/IRB for study purposes and supporting responses to RA/IRB requests as applicable
• Support submission of expedited reports (e.g., SUSAR) and periodic/annual updates to RA/IRBs and other applicable local bodies in accordance with national requirements
• Support applications for unapproved goods for clinical trials including as applicable drug and laboratory kit importation and exportation to applicable authorities in accordance with national requirements
• Providing regular project status updates about RA and IRB submissions to Global/Regional Regulatory Lead(s) and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Maintain up-to-date knowledge of the local/regional clinical trial laws, regulations, and guidelines to perform the assigned regulatory responsibilities.
• Participating in regulatory activities within the company and ensuring regulatory (RA and IRB) related activities are performed according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Regulatory review of documentation to ensure compliance with national, regional and/or international requirements
• May be requested to support Business Development in review of proposals and /or attendance at bid defense.

QualificationsMinimum Required:

• Bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline
• Prior clinical research and >3 years regulatory submissions experience
• Computer literacy (MS Office/Office 365
• Eligible to serve in a CTA Holder/Local Sponsor capacity, as required

Preferred

• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC (or equivalent) certification/Masters in Regulatory Sciences
• Fluent in English
• Specialised knowledge of regulatory activities including but not limited to regulatory submissions to RAs and IRBs
• Knowledge and expertise in ASEAN guidelines and applicable country regulatory concerning the conduct of clinical trials
• Knowledge and expertise in GCP/ICH guidelines

Competencies

• Effective communicator
• Ability to manage multiple and varied tasks in a fast-moving environment
• Excellent record-keeping skills
• Good interpersonal skills and proven ability to contribute to a team environment
• Flexible attitude with respect to work assignments and new learning opportunities

Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for n ovel therapeutics in various indications.Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .