(Senior) Regulatory Affairs Specialist

(Sr.)Regulatory Affairs Specialist-South Korea-ICON Strategic Solutions

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Senior Regulatory Affairs Specialist at ICON, you will ensure regulatory compliance and facilitate the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.

What You Will Do:

Responsibilities:

• 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-functional 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

Qualification and Requirements:

• 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 Procedures
• English Proficiency
• Good communication skill for external and internal interaction
• Good computer literacy skills, comfortable working with database

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply