Job Description

Senior Regulatory Affairs Specialist (Medical Devices)

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, health and gastroenterology, in addition to products and services across its Aesthetics portfolio. They are currently looking for Senior Regulatory Affairs Specialist

Primary Function:

• Plan and prepare regulatory submissions of therapeutic products and medical devices.
• Utilizing good understanding of regulations for therapeutic products and medical devices, interpret regulations and provide regulatory strategies and recommendations.
• Support registrations, lifecycle management activities and ensure regulatory compliance is maintained. Monitor emerging trends regarding industry regulations to determine potential impact on organizational processes.

Responsibilities:
Regulatory:

• Keep up to date for product registration, variation, line extension and other related legislations and regulations knowledge for therapeutic products and medical devices.
• Monitor and disseminate information on changes by the local Regulatory Authority including legislations and regulations affecting registration, manufacture, distribution, sale and marketing of AbbVie products.
• Facilitate communication between Area Regulatory Lead, Affiliate Brand Team and the local Regulatory Authority.
• Update local RA SOPs following updates to regulations and processes and conduct periodic review of these SOPs.
• Streamline RA processes to increase productivity.
• Maintain good knowledge of relevant corporate policies and ensure compliance.
• Other regulatory projects and tasks assigned by RA Manager.

Product registration and approval:

• Develop registration strategies, prioritize assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets with guidance from RA Manager, where required.
• 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, assess its impact on AbbVie\'s business and communicate changes in a timely manner to relevant parties and management.
• 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 and management, as required.
• Communicate regulatory issues and evaluate the impact on the business to management, Business Unit, and to General Manager where applicable, under the supervision of 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 and provide updates on registration status during brand team meetings, as applicable.
• Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.
• 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 3 years\' experience in regulatory function and in-depth knowledge of Singapore Regulations in therapeutic products and medical devices.
• Understands business needs and impact of regulatory issues.
• Experience in medical device regulatory framework

Lim Pey Chyi - Apple.lim@manpower.com.sg
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423

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

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