Regulatory Affairs Partner (1 Year Contract)

1-3 years

Not Disclosed

Remote

10 Feb. 13, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Partner (1 Year Contract)

Location: Victoria, Hong Kong
Category: Regulatory Affairs
Job ID: 202502-103518

Position Overview

At Roche, we are committed to innovation and access, ensuring that every patient receives the care they need at a lower cost to society. We are looking for a Regulatory Affairs Partner to join our Hong Kong team on a 1-year contract. In this role, you will play a vital part in ensuring the successful regulatory approval and compliance of Roche's products, contributing to the company's mission of improving patient outcomes through innovation.

Purpose of the Role

The Regulatory Affairs Partner will contribute to accelerating access to Roche's innovations by supporting the preparation of regulatory submissions and compliance activities. This role is designed to enable value creation for patients while supporting the regulatory team in maintaining high standards for Roche's licensing and regulatory processes.

Key Responsibilities

Support Regulatory Strategy Implementation:
- Assist in realizing regulatory strategy and contribute to the successful submission of materials for regulatory approval.
Document Compilation & Submission Preparation:
- Coordinate the collection of documents, records, reports, and data for inclusion in regulatory submissions, license renewals, and other related activities.
- Help with preparation for product approvals, including New Chemical Entities (NCEs), import licenses to Macau, and applications for the Greater Bay Area.
Labeling & Advertising Compliance:
- Assist in reviewing product labeling and advertising materials to ensure they comply with regulatory requirements and standards.
Support Regulatory Operations & Systems:
- Contribute to the efficient operation and maintenance of regulatory processes and systems.
- Stay up to date with regulatory changes, procedures, and industry practices, ensuring compliance with evolving standards.
Cross-Functional Collaboration:
- Support cross-functional teams, including the License to Operate Team and affiliate departments, to ensure smooth regulatory operations.

Who You Are

Qualifications:

1-3 years of experience in Hong Kong drug regulatory affairs (preferred).
Bachelor’s degree or above in a science-related discipline.

Capabilities:

Attention to Detail: High accuracy and precision when executing regulatory tasks.
Adaptability & Problem-Solving: Ability to thrive in a changing environment, proactively identifying opportunities while ensuring compliance.
Compliance Focus: Dedication to maintaining Roche Hong Kong and Macau’s License to Operate by adhering to regulatory standards.

Mindset & Behaviors:

Roche Values: Integrity, Courage, and Passion in all actions.
Leadership Commitment: Embody Roche Leadership values and demonstrate key competencies.
Growth Mindset: Ability to learn quickly, take risks, and contribute to the learning cycle by sharing knowledge within Roche.
Value Creation: Ability to act decisively on key opportunities and say "No" when value is not clear.
Digital Innovation: Embrace digital transformation in healthcare to drive value and impact.
Enterprise Thinking: Think broadly across organizational boundaries to deliver the best outcomes locally and globally.
Agility & Collaboration: Work flexibly with internal and external networks, leveraging resources to scale impact.

Why Roche?

At Roche, we foster an inclusive and diverse environment where every voice matters. By joining our team, you will have the opportunity to contribute to meaningful healthcare innovations and help shape the future of healthcare across Hong Kong and Macau. With a focus on growth, value creation, and digital transformation, Roche offers a dynamic environment for individuals who are passionate about making a difference in the world of healthcare.

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