Job Description

Regulatory Affairs & Quality Assurance Manager

Job Scope

• Obtain fast new drug approvals through preparation of the required documentation and thorough follow-up with local health authorities.
• Variations and renewals of already approved drugs.
• Proactively identify regulatory trends and communicate potential impacts on company business.
• Adhere strictly the timelines in Corporate SOP for submitting the registration information to RIMS Data Entry Team and verifying RIMS data in REGISTER.
• Preparation of technical dossiers for price submission and tender application
• Processing and reporting to GPV and Health Authorities all safety information received from market, post-authorisation studies, scientific literature and Health Authorities in accordance with national legislation and internal procedures.
• Manage the product quality complaint process and handle product recalls.
• Provide training to all employees and local agent(s) with regard to safety reporting, complaint management, and product recall
• Perform disposition of finished products for distribution or delegate the task to appropriate trained individuals
• Provide QA oversight of activities performed by distributor
• Act as the Management Representative for FPPL to ensure that the processes needed for the local quality management system are established, implemented and maintained.
• Responsible for Singapore and Myanmar markets
• Compliance office role for Singapore

Requirements

• Degree in Pharmacy
• A registered pharmacist in Singapore
• At least 5 years of Regulatory Affairs working experience
• Direct experience of working with Regulatory Authorities
• Knowledge of international guidelines and national legistration related to drug registration and Pharmacovigilance
• Capable of developing and implementing regulatory strategy

EA License No. 01C4394 \xe2\x80\xa2 RCB No. 200007268E \xe2\x80\xa2Derrick Tiew Yong Han EA Registration No. R1877971

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Additional Information

Career Level

Manager

Qualification

Bachelor\'s Degree, Post Graduate Diploma, Professional Degree

Years of Experience

5 years

Job Type

Full-Time

Job Specializations

,

Company Overview

PERSOLKELLY is one of the largest recruitment companies in Asia Pacific providing comprehensive end-to-end workforce solutions to clients.

Headquartered in Singapore, the company was established in 2016 and is a joint venture between Kelly Services, Inc. and affiliates of PERSOL HOLDINGS Co. Ltd.

Today, PERSOLKELLY operates more than 45 offices across 13 markets including Australia, China, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand, and Vietnam.

Our deep market understanding and industry expertise, honed over four decades of operations in Singapore, gives us an edge in driving business change and empowering your organisation to overcome future HR challenges. We combine our expertise with genuine human insights to provide strategic solutions for your HR needs. Our team will partner with you to enhance your HR practices, so you can confidently achieve more.

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its local and overseas subsidiaries and affiliates collecting, using and disclosing your personal data to prospective employers/companies based in any country for purposes of evaluating suitability for employment, conducting reference checks, administering employment related services, complying with Government\'s COVID-19 health advisories and such other purposes stated in our privacy policy. Our full privacy policy is available at www.persolkelly.com.sg. If you wish to withdraw your consent, please drop us an email to let us know. Please feel free to contact us if you have any queries.

Please visit www.persolkelly.com.sg for a copy of our Privacy Policy.

For more information, please visit www.persolkelly.com.sg

Additional Company Information

Registration No.

200007268E

EA No.

01C4394

Company Size

51 - 200 Employees

Average Processing Time

8 days

Industry

Human Resources Management / Consulting

Singapore Post