Director, Regulatory Affairs

"At ICON, it's our People that set us Apart"

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. ICON Clinical Research is Whole Owned Foreign Company which founded in 1990 in Ireland.

We expanded our business from 1996 in APAC region.

Job Title: Director, Regulatory Affairs

Location:  Korea 

ICON is currently looking for a Director, Regulatory Affairs to join the Global Regulatory Affairs consulting team. As a Director, RA, you will work in Global Regulatory Affairs and form part of Asia-Pacific Regulatory team, a successful and driven team that provides consultancy for all ICON projects globally as well as standalone contracts with clients. You will have the responsibility for driving and developing the Korea regulatory business especially aimed at clients based inside the Korea whose interest is in filing with the Korea regulatory bodies. The Director provides expert advice/strategy and opinion to clients within the Korea Regulatory environment. This position is a management, business and expert role.

Responsibilities

- Provide strategic direction and management for clients on Korea regulatory issues.

- Effectively oversee the preparation of regulatory submission documents in adherence with applicable Regulations and Directives for submission to government agencies.

- Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project team. Building positive working relationships with clients and government agency contacts.

- Review and/or create study reports, clinical protocols, safety and efficacy reports for accuracy and compliance to regulations. Review of draft submissions for regulatory content and the editorial viewpoint.

- Responsible for managing project workflow including prioritizing project objectives, and establishing time frames for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring time frames and deadlines are met.

- Lead and participate in formal interactions (face-to-face meetings, teleconferences, etc.) with clients and government agencies. Build positive working relationships with clients and government agency contacts.

- Interact with potential clients to develop new business and create win-win agreements.

- Identify project issues and develop alternate strategies for presentation to client. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.

- Participate in or conduct quote preparation and new project / client consultations.

- Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers, advising on regulatory issues and strategies.

- Present industry related training seminars or workshops at industry conferences.

- Participate in the planning and execution of the strategic direction for the Korea business.

Additional Functions/Responsibilities as Regulatory Project Lead; 

- Primary point of contact between ICON and the Client

- Management of the designated project in accordance with the agreed project planning and control documentation, including initiation and maintenance of the project plan

- Management of the assigned regulatory project team

- Production of project status reports at agreed intervals

- Ensuring that checking and auditing procedures are carried out

- Control of all project related documentation either in paper or electronic form

- Monitoring and advising on compliance with agreed budget relating to the project

Requirements

- Significant experience of pharmaceutical / biologics development in Korea regulatory environment, including leadership and/or senior consulting experience.

- Expert knowledge and understanding of the development process for pharmaceutical and Biological products including: CMC, non-Clinical and Clinical

- Working knowledge of venture capital and credit markets and their role in drug development

- Strong knowledge of a variety of computer programs including MS Office, Adobe Acrobat, and eCTD compiling software, etc.

- Displays full knowledge of protocol, regulatory requirements, and company SOPs. Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety.

- Advanced degree (M.Sc., Ph.D., M.D., Pharm.D.) in the Pharmacy, Medical, Biological, Chemical or Engineering. BSc required.

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.

We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

 You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017.

If you would like more information please visit our company website: www.iconplc.com  or https://careers.iconplc.com or feel free to email me directly: Jennifer.kim@iconplc.com