Regulatory Affairs Manager I - SGP

one stop engineering pte. ltd.; Singapore; Vor Ort; SGD 120.000 - 180.000; Vollzeit

Zusammenfassung

one stop engineering pte. ltd. in Singapore seeks a Regulatory Affairs professional to support JAPAC and Global RA in MA and lifecycle management for assigned projects.

You will interact with regulatory agencies and cross-functional teams to implement regulatory strategies aligned with regional priorities, ensuring data packages meet regional requirements and timelines.

Qualifikationen

• BS degree in pharmacy, pharmacology, biology or related subject.
• Minimum 5 years’ experience in Regulatory.
• In-depth knowledge of JAPAC regulatory requirements preferred.

Aufgaben

• Supports JAPAC RA affiliates and Global RA in Marketing Authorization (MA) and lifecycle management related activities for assigned projects.
• Manages interface with internal and external regulatory and cross-functional stakeholders, including direct/indirect interaction with regulatory agencies.
• Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
• Partners with intercontinental commercial, market access and medical to ensure business needs are met.
• Represents the JAPAC regulatory function at sub-teams to present regulatory requirements or provide strategic input for the registration of products.
• Assesses scientific data for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
• Manages clinical trial, new drug applications and lifecycle activities for the assigned projects to ensure regulatory requirements are met and optimal regulatory strategies are reached.

Kenntnisse

Interpersonal skills

Communication skills

Negotiation skills

Ausbildung

BS degree in pharmacy, pharmacology, biology or related subject

Jobbeschreibung

Major Responsibilities:

• Supports JAPAC RA affiliates and Global RA in Marketing Authorization (MA) and life cycle management related activities for the assigned projects.
• Manages interface with internal and external regulatory and cross-functional stakeholders, including direct/indirect interaction with regulatory agencies.
• Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
• Partners with intercontinental commercial, market access and medical to ensure business needs are met.
• Represents the JAPAC regulatory function at sub-teams to present regulatory requirements or provide strategic input for the registration of products.
• Assesses scientific data for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
• Manages clinical trial, new drug applications and lifecycle activities for the assigned projects to ensure regulatory requirements are met and optimal regulatory strategies are reached.

Education / Experience Required:

• BS degree in pharmacy, pharmacology, biology or related subject.
• Minimum 5 years’ experience in Regulatory.
• In-depth knowledge of the regulatory requirements of the countries within the JAPAC region is preferred.
• 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 and relevant stakeholders.
• 1 year continuous rolling contract

Accountability / Scope:

• The incumbent is accountable for representing RA in in intercontinental cross-functional teams and so to ensure that business priorities, global, area and affiliate RA strategies are aligned.
• The incumbent is expected to analyse, understand and communicate changes in regulatory requirements that may impact the data requirements or timelines for gaining and/or maintaining marketing authorization applications.
• The incumbent is expected to contribute to process optimization projects initiated by the JAPAC / global team

Problem Solving:

• The incumbent is expected to be able to identify potential issues that may impact the regulatory strategy and timeline for products of responsibility and to develop solutions to mitigate the risk and outcome.
• The incumbent should have strong communication and negotiation skills in order to be able to reach mutually agreeable solutions on regulatory related issues with cross-functional stakeholders at affiliate, area and global levels.

Teleconferences (outside of office hours)

Represent JAPAC Regulatory in global/area meetings.