Job Description

Description

Aesthetics Regulatory Associate Director #HMS
up to 12k
medical device
Mapletree
6 months

• 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.
• \xc2\xb7 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.
• \xc2\xb7 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.
• \xc2\xb7 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.
• \xc2\xb7 Actively supports R&D and affiliate regulatory and clinical operations teams in securing timely approval of registrational clinical trials.
• \xc2\xb7 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.

Interested candidates, do submit your reusme to:
Telegram me at @jocelynchan

Jocelyn Chan
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

Healthcare - Nurse / Allied Healthcare
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs

Location

Central, North, East, West

Employment Type

Part-time
Contract / Temp
Permanent

Salary

Negotiable

If you meet the requirements of this role, please email a detailed resume in Word document to Jocelyn Chan.
CEI Registration No.: R1331820
Email: jocelynchan@recruitexpress.com.sg
Tel: 67363280
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express