Job Description

Regulatory Affairs Specialist (Medical/ Therapeutic Products)

12-Months Contract
Location: Buona Vista
Salary: Up to $6500 depending on experience
Completion Bonus

Our client, a MNC company with the mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people\'s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, and gastroenterology, in addition to products and services across its Aesthetics portfolio. They are currently looking for Regulatory Affairs Specialist

Primary Function:

• Plan and prepare regulatory submissions of therapeutic products.
• Support registrations, lifecycle management activities and ensure regulatory compliance is maintained

Responsibilities:
Regulatory:

• Keep up to date for product registration, variation, line extension and other related legislations and regulations knowledge for therapeutic products.
• Facilitate communication between Area Regulatory Lead, Affiliate Brand Team, and the local Regulatory Authority.
• Maintain good knowledge of relevant corporate policies and ensure compliance.
• Other regulatory projects and tasks assigned by RA Manager.

Product registration and approval:

• Review, analyze and coordinate data for new product submissions, line extensions according to priorities and responses to deficiency letters. Ensure that the contents comply with local regulations and timelines prior to submission to the Regulatory Authority.
• Maintain an awareness of country\'s regulatory legislation.
• Monitor progress of marketing applications through the regulatory system.
• Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
• Report progress and status to RA Manager.

Product maintenance:

• Up to date of medical device and product registration, variation, line extension and other knowledge related to legislations and regulations.
• Review, analyze and co-ordinate data for variations submission to marketed products according to priorities and responses to deficiency letters.
• Monitor progress of variations applications.
• Liaise and negotiate with the Regulatory Authority to facilitate and secure expeditious regulatory approvals.
• Manage labeling changes, artwork development and artwork approval of packaging material components.
• Update and maintain regulatory databases.

Support marketing activities:

• Monitor the progress of marketing applications.
• Review and provide input and approval on promotional materials, product information and labels to ensure compliance with relevant regulations and codes.

Requirements:

• Bachelor\'s Degree in Pharmacy, Biological Sciences, Life Sciences or Pharmaceutical related studies

• Minimum 2 years experiences in regulatory function in a pharmaceutical and medical device
• Understands business needs and impact of regulatory issues

If you possess above relevant skillsets, please send in your updated CV in word format to Apple.lim@manpower.com.sg

Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup\'s Global Privacy Policy, please visit https://www.manpower.com.sg/privacy-policy

Manpower