The Opportunity:

Under general supervision, prepare and submit documents necessary to gain US and foreign regulatory approval / clearance to place new or modified products into worldwide commercial distribution. Provide expertise, make recommendations and give regulatory direction as an integral member of product development and supply chain teams. Regulatory representative on new product development teams to ensure compliance with internal company requirements and compliance with regulatory requirements.

SUMMARY:

Responsible for strategy for product registration, evaluation, compilation, and preparation of registration dossiers across the Korea region. Responding to regulatory queries from authorities, and customers with minimum guidance. Direct interaction with regulatory authorities, provide regulatory trainings to all concerned parties with a good sense of maturity and understanding that lead to significant impact on company’s business growth in the region. Provide regulatory guidance to management or development project teams regarding design, development, evaluation, or marketing of various products including but not limited to chemicals, excipient, equipment, consumables and medical devices. Good knowledge and understanding on Korea regulations and issues.

JOB REQUIREMENTS:

Provide Regulatory guidance to Korea business that have significant impact on strategy of new launches of various products including chemicals, Biopharma excipients, medical devices etc.Act as a local contact with authorities in Korea – participating on declarations & reporting, permits/licenses requests, inspections and other activities.Responsible for legal tracking, vigilance, regulatory guidance and regulation interpretations that impact the business.Develop team spirit and teamwork within the assigned hubSets operational goals in conjunction with the defined strategic priorities Identify problems and update working methods in own role with the benefit of defined procedures.Keeps informed of regulatory regulations & changes.In cooperation with other stakeholders, he/she implements the necessary changes to maintain company compliance, including SOPs & instructions and local regulatory requirements when required.Give input and work together with Sales/Supply Chain/Customer Services to secure compliant products are placed on the market.Provide professional support/training on expert subject to customers and internal stakeholders on request.Support for central projects with local implementations.Communicate and update Central REGA on all local activities - inspections, update in legislation, license requirements and others.Collaborate and support Local QA/Sales for customer-facing activities.Work collaboratively across functions/sites to support customer inquiries as required and Regulatory agreements to protect our business and that compliance/customer requirements are established properly.Performs other duties as assigned to support local regulatory and quality.

QUALIFICATIONS:

Bachelor/master’s degree in chemistry, Biochemistry, Microbiology, and other Science related course.Experience with domestic and international regulatory filings and interactions with regulatory authorities required.

REQUIRED SKILLS AND EXPERIENCE

Good knowledge and understanding of Korea regulations on chemicals, excipients, Medical Devices with 5- 8 years of relevant experience in regulatory and compliance matters in chemicals/excipients/Life science companies.High level of professionalism and maturity combined with the ability to interface the Korea team within and outside the organization.Ability to interpret Korea regulations and compliance documentsIntellectually curious and a willingness to adapt and learn about new areas of regulations.Able to work hard and deliver under pressure, establish priorities, and coordinate work activities simultaneously.Excellent Analytical skills, interpersonal skillsOpen minded and team player in a multicultural environmentAbility to develop innovative strategies and creative solutions within the regulatory context

 

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

3rd party non-solicitation policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation