Senior Manager 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 1995 in APAC region.

Job Title: Senior Manager Regulatory Affairs

Location:  Korea
Type: Full time, permanent / office based or home based

The Position

ICON is currently looking for a Senior Manager Regulatory Affairs to join the Global Regulatory Affairs consulting team. As Senior Regulatory Manager, 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 support the Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and deal directly with the sponsor and Regulatory Agencies

Responsibilities
- Effectively manage Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON.

- Duties will be variable depending on the nature of the projects to be undertaken.  These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs. Works on a range of regulatory issues in which analysis of situations or data requires an in-depth evaluation of diverse factors.

- May work either alone or as part of a regulatory or cross-functional team depending on the size and nature of increasingly complex projects.

- Act as Regulatory Project Lead but may also report to another Regulatory Project Lead as required.

- If acting as Regulatory Project Lead, responsible for managing each project and for monitoring and reporting progress and is accountable for all matters relating to that project and for communication with the client.

- Represent the Regulatory Affairs Department in business development activities.

- To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.

- Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.

- As a manager, the employee is expected to recognize the importance of and create a 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 to 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.

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

- Minimum five years Pharmaceutical/CRO within Regulatory Affairs in a similar role

- In depth proven experience in regulatory affairs or aligned work

- Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction

- Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.

- Excellent written and communication skills

- Good written and spoken English.

- Proficient in the use of Microsoft Office.

- Bachelor’s degree, or local equivalent, preferably in the sciences, or equivalent experience qualification. Masters degree or higher preferred.

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.