Job Description

Senior Regulatory Affairs Specialist (JAPAC/ Aesthetic Fillers)

12-Months Contract
Location: Buona Vista
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:

• To act as the representative of the regulatory affairs organization to the JAPAC commercial organization for all aspects related to the assigned therapeutic area and products of responsibility.
• Define and implement the Area & Affiliate regulatory strategies and deliverables for a portfolio of compounds (early development, late development, marketed) for the JAPAC Area.
• Monitoring and influencing changes in regulatory policy and intelligence for the country or countries of responsibility.
• Represent RA in any cross-functional initiatives being led out of the JAPAC commercial offices.
• Provide regulatory guidance and support of medical device/combination products to team member and across TAs.

Major Responsibilities:

• Primary interface to and from the RA personnel in the affiliates.
• Primary interface with local health authorities via RA personnel in the affiliates.
• Provides leadership and support to RA personnel in the affiliates. Assesses scientific data provided by specialist units for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps. Ensure effective presentation of data, complete and timely responses (including CTAs).
• Primary RA interface with Commercial. Represent RA at cross-functional teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).
• Primary RA interface with Clinical Development by providing strategic clinical development input from a regulatory perspective.
• Designs and implements Area Regulatory Strategic Tactical Plan for assigned projects for countries in JAPAC region in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
• Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met.
• Maintains, monitors and provides input on the regional regulatory environment and policies to understand new regulations, assess implications to the business, develop and execute strategies to respond to the regulations.
• Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial R&D, CMC, Operations, etc.) to present regulatory requirements or provide strategic input for the registration of products.
• Actively supports R&D and affiliate regulatory and clinical operations teams in securing timely approval of registrational clinical trials.
• Lead the development of training programs and other area regulatory initiatives for JAPAC affiliates.
• Ensure regulatory compliance within JAPAC for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
• Coaches and mentors other more junior team members in their project, in addition to products assigned to oneself. Transfer knowledge to the Therapeutic Area.

Requirements:

• BS degree in pharmacy, pharmacology, biology or related subject.
• Minimum 7 years\' experience in Regulatory. At least 5 years\' experience in JAPAC regulatory in new medical device and/or drug applications for NCEs and clinical trial development.
• Have in-depth knowledge of the regulatory requirements of the countries within the JAPAC region
• Regulatory and development experience in medical device for aesthetics indications would be ideal
• Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful.
• Proficiency in communicating strategic and tactical issues to management.

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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