Drug Regulatory Affairs Partner

0-2 years

Not Disclosed

Copenhagen

10 Jan. 2, 2025

Job Description

Job Type: Full Time 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: Drug Regulatory Affairs Partner
Location: Denmark and Iceland
Category: Regulatory Affairs

About Roche:
Roche fosters a culture of diversity, equity, and inclusion, reflecting the communities we serve. In global healthcare, diversity is crucial for success, and we believe inclusion is key to understanding the diverse healthcare needs of people worldwide. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position:

The Opportunity:
Roche Pharmaceuticals A/S is seeking a committed and energetic Drug Regulatory Affairs Partner with a structured and quality-oriented mindset. In this role, you will be part of a small, dedicated team that handles regulatory, GxP, and compliance tasks, often with short deadlines. You will be responsible for driving regulatory tasks and making an impact on the business within an active and flexible working environment.

Your Responsibilities:

Assume regulatory responsibility for assigned products in Denmark and Iceland.
Coordinate and prepare document packages for regulatory submissions for new products and Life Cycle Management submissions for registered products.
Proofread regulatory texts in the local language.
Manage artwork changes related to Lifecycle Management, including initiating, creating manuscripts, proofreading, and approving artworks.
Ensure that corporate regulatory data and document management systems are up to date.
Stay informed about regulatory legislation, procedures, and changes in the regulatory landscape to ensure compliance.
Interact directly with regulatory agencies.
Actively engage and support business and disease area teams with regulatory details, timelines, and information related to products.
Coordinate with Roche HQ to support Scientific Advises with the Danish Health Authorities, particularly when Denmark acts as the Rapporteur Country for EMA.
Implement new systems and train new colleagues.
Maintain procedures to ensure compliance with regulatory legislation.

Who You Are:

A Master's degree in pharmacy, pharmaceutical sciences, or a related field.
A strong personality with the ability to thrive in a regulated area.
Systematic, flexible, and with strong interpersonal skills.
A team player who can work both independently and effectively cooperate with others.
Fluent in Danish and English, both spoken and written.
Ability to take initiative and express yourself effectively in a professional environment.

If you have questions, feel free to contact Sandra Stendal, Head of License to Operate, at +45 24 88 60 52 for further information.

Who We Are:
At Roche, over 100,000 people across 100 countries are pushing the boundaries of healthcare. Together, we have become one of the world’s leading research-focused healthcare groups, driven by innovation, curiosity, and diversity.

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Drug Regulatory Affairs Partner

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