Associate Labeling Manager

0-2 years

Not Disclosed

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: Associate Labeling Manager

Location: Welwyn, Hertfordshire, United Kingdom
Category: Regulatory Affairs
Job ID: 202501-102788

Position Overview

At Roche, our passion for innovation drives us to advance science and ensure equitable access to healthcare for all. As an Associate Labeling Manager, you will play a key role in shaping the regulatory strategy for Roche’s pharmaceutical products and devices, ensuring the accuracy and clarity of product information across the global product lifecycle. This role is within the PD Regulatory Program Management Chapter, which focuses on regulatory strategies and clinical development, working with cross-functional teams to maintain product permits/licenses that meet patient needs.

Key Responsibilities

Regulatory Labeling:
- Contribute to the development and maintenance of the Core Data Sheet (CDS), core Patient Product Information (cPPI), and local product labels for the EU and US markets throughout the product lifecycle.
- Ensure compliance with all labeling requirements and that product information is clear, accurate, and effective.
Documentation & Communication:
- Lead or assist in preparing company documents and responses to Health Authority requests related to product labeling, ensuring regulatory clarity and compliance.
- Ensure all labeling activities align with global regulatory standards and that updates to the CDS are communicated and implemented correctly across local labels.
Collaboration & Stakeholder Engagement:
- Work closely with product teams, country affiliates, and other stakeholders to ensure consistency in product information and regulatory labeling.
- Partner with key stakeholders to support Roche’s goals in molecule portfolio management and contribute to strategic initiatives.
Compliance & Risk Management:
- Ensure Roche maintains its License to Operate by complying with regulatory requirements, corporate policies, and medical compliance standards, including adherence to the Roche Group Code of Conduct.
Trend Awareness & Strategy:
- Stay informed on regulatory trends, developments, and competitor activities to ensure proactive decision-making in labeling strategies.
Standard Operating Procedures (SOPs):
- Contribute to the creation and implementation of new PDR-specific Standard Operating Procedures (SOPs) and systems to streamline the content creation and tracking process, ensuring end-to-end labeling compliance.

What You Bring

Educational Background:
- A degree in a relevant field (e.g., pharmacy, biology, chemistry, or similar).
Experience:
- Experience in regulatory affairs, particularly in labeling and managing product information.
- Familiarity with global labeling standards and regulations, particularly in the EU and US markets.
Skills:
- Strong attention to detail, with the ability to convey complex regulatory information in a clear and concise manner.
- Ability to collaborate effectively with cross-functional teams and stakeholders at all levels.
- Critical thinking and problem-solving skills, especially when addressing regulatory challenges.
Compliance & Knowledge:
- A solid understanding of the regulatory landscape, including labeling requirements and health authority communication.

Why Roche?

At Roche, we believe in fostering an environment where diversity, equity, and inclusion are fundamental to success. Join us to be part of a global organization that prioritizes innovation, patient outcomes, and an inclusive workplace culture where every voice is valued. This position offers an opportunity to contribute to Roche’s global regulatory strategy, ensuring that patients worldwide have access to the medicines they need.

How to Apply

If you are ready to take on this exciting opportunity to shape Roche’s regulatory labeling strategy, apply today and become part of a company committed to improving lives. We look forward to hearing from you!

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Associate Labeling Manager

Job Description

Job Title: Associate Labeling Manager

Position Overview

Key Responsibilities

What You Bring

Why Roche?

How to Apply

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