Job Description

Description

Major Responsibilities:

• Supports JAPAC affiliates and Global Regulatory Affairs in Marketing Authorization (MA) related activities for the assigned projects
• Interfaces with affiliates for the assigned projects, including direct/indirect negotiation with regulatory agencies.
• Implements regulatory strategies for the assigned projects for countries in JAPAC under supervision, in line with area commercial priorities and in collaboration with the Global Regulatory Lead and other RA sub-team colleagues.
• Partners with Intercontinental commercial teams to ensure business needs are met.
• Represents the JAPAC regulatory function at sub-teams to present regulatory requirements and commercial interests on the Global Regulatory Product Team (GRPT) to ensure those are met.
• Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial, R&D, CMC, etc.) to present regulatory requirements or provide strategic input for the registration of products.
• Interfaces with Clinical Development as appropriate
• Assesses scientific data provided by specialist units for registration purposes against JAPAC regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps. Ensures effective presentation of data, complete and timely responses.
• Compiles and/or prepares regulatory dossier or documents to fulfil local registration requirements in a timely manner.
• Ensures regulatory compliance for the assigned compounds/products. Implements remediation plan to address identified gaps, if any.
• Supports area regulatory initiatives for JAPAC affiliates.

Education / Experience Required:

Min degree in pharmacy, biomedical engineering, pharmacology, biology or related subject.

Minimum 3 years' experience in regulatory with experience in JAPAC

Have in-depth knowledge of the regulatory requirements of the countries within the JAPAC region

Experience with medical device regulation, while not a prerequisite is advantageous

Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful.

Proven interpersonal skills.

Strong proven personal development and motivational skills.

Proficiency in communicating strategic and tactical issues to management.

If you meet the requirements of this role, please email a detailed resume to alexgoh@recruitexpress.com.sg.

Alex Goh Hock Leong (Alvin)

(CEI.No: R1763413

Recruit Express Pte Ltd (Healthcare & Life Science)

99C4599

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Legal & Compliance

Location

West

Employment Type

Contract / Temp

Salary

S$4,001 - S$6,000 / mth

If you meet the requirements of this role, please email a detailed resume to alexgoh@recruitexpress.com.sg.

Alex Goh Hock Leong (Alvin)

(CEI.No: R1763413

Recruit Express Pte Ltd (Healthcare & Life Science)

99C4599

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.