天津招聘

职位描述：
Regulatory Affairs Manager
SUMMARY
? A Regulatory professional who contributes to drug development, as part of the Regulatory Affairs team, through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing applications and post approval support
? Manager Regulatory Affairs is Regulatory professional who will have prior experience with several areas of Regulatory affairs (CTA/IND/ MAA) and the ability to lead internal teams and carry out regulatory activities and submissions independently
? May work as part of a regulatory or cross-functional team depending on the size and nature of project
? Contributes to ICON Regulatory Affairs through their understanding of Regulatory process and interpretation of guidelines to develop best practices
JOB FUNCTIONS/RESPONSIBILITIES
? Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance.
? As a member of staff, the employee is expected to embrace and contribute to ICON culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
? To be familiar with and work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.
? Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken and be capable of supporting or developing regulatory strategies or solutions as appropriate to level of expertise
? *As member of the Regulatory Affairs team, you will be required to have in-depth experience with at least one of the following activities, and aim to gather experience in several, working mainly independently; for complex projects with a mentor:
o Preparation, compilation and submission of routine Regulatory submissions e.g. CTA /IND, Variations / lifecycle submissions, Annual reports to IND, orphan designation or PIP
o Be Client POC/ Alliance POC for complex CTA programmes and ICON Alliance partners
o Be responsible for Agency submissions (e.g. IND, CIND, Japan CTN, new EU CTR submissions)
o Contribute to specialised submission preparations and Agency interactions (Adaptive Pathways, Fast track Designation, priority review)
o Lead preparation and review of Agency Briefing documents
o Take a major, client facing role in to more complex projects (early development, MAA/NDA, Post Marketing) contributing to (for example) review and compilation of documents for Scientific advice/variations/MAA, document product label review, translation requirements, fee requirements and payments, submission planning
o Act as lead for routine post marketing submissions including artwork review, centralised labelling procedures
o Support Regulatory Intelligence
o Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON
o Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required
o Support to more senior team members on more complex projects
? *Travel (approximately 10%) domestic and/or international.
? *Undertake all required tasks requested to meet departmental and project goals, as appropriate
? *Participate in regulatory and/or clinical trial project teams as required.
? *Responsible for timely and accurate completion of assigned projects and for timely identification of issues including the need for change orders.
? *Identify department process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department’s goals.
? *Identify issues, proactively seek advice and address them in a timely manner, including development of preventative actions (as necessary under supervision)
? *Assist in review or update of existing department standard operating procedures
? *Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
? *Maintain an accurate record of the time associated with each allocated activity and ensure compliance with all timekeeping and tracking systems
? In addition as required, you may be requested to
o Initiate product research and regulatory intelligence searches in support of designated regulatory activities, and provide information on regulatory requirements.
o Provide support to business development activities
o Support or conduct other activities as assigned.
REQUIREMENTS:
? Prior relevant experience in Regulatory Affairs in the pharmaceutical or pharmaceutical contract service industry.
? A minimum of 5 years’ experience in Regulatory affairs in the pharmaceutical or pharmaceutical contract service industry.
? Being an active member of the Regulatory and ICON teams:
o Actively participate in project (CT) team meetings
o Effectively contribute to sponsor or internal projects (e.g. reg intel, process reviews etc.), by delivering on time to the expected quality standards and challenging the status quo, when appropriate.
o Ability to work to procedures and propose improvements when appropriate.
o Curious and willing to ask questions
o Identify issues and proactively seek advice
o Have ability to explain regulatory requirements
? Strong organizational skills, ability to manage multiple tasks by setting/agreeing on priorities and meticulous attention to detail.
? Be solution orientated and own the delivery and commitment on behalf of ICON.
? Be able to solve problems in pro-active and timely manner
? Good written and verbal communication skills.
? Good written and spoken English.
? Proficient in the use of Microsoft Office.

If you are interested in this position, pls for free to contact y Apple.Tang@docsglobal.com

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.