RA Manager

Alcon are one of Korea ‘Top Employer’s’ and are the market leader in eye care globally, helping people see better through advanced surgical and vision care products and if you want to help make a difference then please join us!

Alcon

Country: South Korea

Job Description

Job Title: RA Manager

Department: Regulatory Affairs

Reports to (Job Title): RA Director

Job Purpose

Ensure timely registration of new Rx, OTC & quasi-drugs, plus maintenance of existing registrations, for Alcon Korea, lead the labelling & promotional material approval process for pharmaceutical products and fulfil all regulatory compliance activities and responsibilities as required.

Major Accountabilities

• To account for the assigned new registration & maintenance projects of Rx, OTCs & quasi-drugs for Alcon Korea
• To develop and execute registration strategy and meet the registration timeline
• To ensure regulatory compliance to secure business continuity – labeling(CCDS), CPDS, post approval variation, RIAR, GMP and DMF management, annual reporting, product renewal, and HA reporting
• To lead internal label review & approval process and promotional material approval process for pharmaceutical products
• To monitor and analyse changes in regulatory environment trend, threats, and opportunities
• To maintain theregulatory database
• To comply with all legal, regulatory, and ethical business requirements in executing the assigned roles and responsibilities as defined in the local regulation and the Corporate procedure

Key Performance Indicators

• Meet the committed registration timeline
• Measurement of regulatory compliance in product registration and maintenance – no overdue in regulatory and quality assurance
• Measurement of collaboration level with key internal & external customers by multiple feedback

Ideal Background

Education

• Minimum: B.A degree in Pharmaceutical., Chemistry, Life Science or other relevant subject matter
• Preferred: Pharmacist

Languages:

• Fluency in both written and spoken Korean and English

Experience

• Minimum: 7 years of experiences in regulatory affairs; experience in the healthcare industry
• Preferred: 10 years or more of experience in OTC or quasi drug RA/ ex-MFDS reviewer

Eligibility Requirements

No reason for disqualification on overseas business trip

Men are required or exempted from military service.

Information on returning employment documents

• All applicants, except those who pass the final round, will be able to claim the return of the submitted employment documents during the period between 14 and 180 days from the date on which employment is confirmed.
• In preparation for the applicant’s request for return, we will keep the documents within 180 days after the announcement date of the final successful candidate, and the documents that have expired return period will be destroyed under the Personal Information Protection Act.
• If the application is submitted on the website or by e-mail, or if the applicant submits it voluntarily without our request, it shall not be returned in accordance with the proviso to Article 11 (1) of the Fairness of the Employment Procedure Act, and if the employment documents are destroyed due to natural disasters or other reasons not liable to us, it shall be deemed to have been returned.
• Applicants who wish to request the return of employment documents under the proviso to paragraph (1) submit a return request (Form 3 of the Enforcement Rules of the Act on the Fairness of Employment Procedures) by e-mail to the person in charge of employment and we send it to the designated address within 14 days from the date the submission is confirmed.