Regional Regulatory Affairs Manager

Job Title: Regional Regulatory Affairs Manager

Working model: Home based

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a "Regional Regulatory Affairs Manager" to work closely with our client, a leading pharmaceutical company.

Overview
Provides an interface to top 10 pharma Regulatory and Global Product Development (GPD) partners within designated sponsor Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA and Central Ethics submissions to regional partners and selected Health Authorities.

The Regional/Global CTA Submission Manager (CTA-SM) is accountable for working with contributing Top 10 pharma business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.

Key responsibilities

• Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required 
• Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
• Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
• Liaise with pharma Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes

Required experience and qualifications

• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable);equivalent relevant professional experience will be considered.
• In-depth understanding and proven execution of CTA and Central Ethics processes globally
• Must have APAC Clinical Regulatory experience.
• Good command of English; Native speaker of Chinese

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know

#LI-ST1

#LI-Remote