(Sr.) Regulatory Affairs Specialist

(Sr.) Regulatory Affairs Specialist, Seoul, South Korea

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:

• To achieve timely & successful product registration in accordance with corporate & local strategies
• To collect any information on new regulations and guidelines and the share it in local RA team
• to ensure compliance with company regulatory policies, regulations and procedures
• Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-fuctional team meeting

Regulatory Planning and Submission

• Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company as required by local regulations
• Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
• Develop local registration plans in alignment with local business and global regulatory strategy
• Monitor progress of submission & coordinate timely responses to all questions from the health authorities
• Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee(CRC) and local change control procedures
• Management of regulatory submissions to support clinical trial activities

Regulatory Intelligence and Interaction

• Responsible to collect new or updated local regulations via various potential sources and keep the local RA team informed
• Ensure a regulatory impact assessment in timely manner
• Close relationships with relevant health authorities and other organizations / key stakeholders to facilitate and develop effective collaboration on regulatory interactions
• Communicate with Regulatory Authorities and local industry groups on regulatory issues

Cross-functional collaboration and support

• Provide regulatory consultation & collaborate with local business stakeholders
• Participates in the promotional material approval process in order to ensure regulatory compliance regarding these promotional material s and activities
• Provide feedback to global and participate in global initiatives when requires

Quality and Compliance

• Timely submission of CCPS, CRC, Renewals, PSUR and other local validation in compliance with internal KPIs
• Ensures that regulatory database is up to date to reflect the current registration status or regulatory requirements
• Ensure that timelines for regulatory review in the e-MLR process are met and promotional materials comply with local regulations
• Contribute to audits, CAPA process as appropriate and support local inspection readiness
• Archiving of local regulatory submission Documents

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You are:

• Degree in Pharmacy preferred
• +3 years of experience in pharmaceutical, medical device or health industry
• Experience in regulatory affairs or relevant discipline is preferred
• Solid understanding of drug development
• Good knowledge of National Drug Regulations and Proceduries
• English Proficiency
• Good communication skill for external and internal interaction
• Good computer literacy skills, comfortable working with database
• GMP 서류 평가 진행하신 경험 있으신 분

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.