Regulatory Labelling Compliance Specialist

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The Position

The Regulatory Labelling Compliance Specialist within the Quality and Compliance Chapter supports the Labelling group and affiliates in the regulatory compliance activities for the entire product life cycle. The Regulatory Labelling department is responsible for developing and maintaining company Core Data Sheet (CDS) for medicinal products and for guiding and supporting the implementation of CDS at country level. Additionally support is provided for basic Quality and Compliance activities within PDR beyond labeling.

The Opportunity:
We are seeking a proactive and highly organized specialist to ensure global labelling implementation compliance across our portfolio.

In this role you will:

• Execute Regulatory Information Management (RIM) Processes by creating Labelling Events and related records and managing Affiliate Submission Extension Requests

• Drive and Monitor Compliance through the timely updating of EU and US tracking information and the generation and proactive analysis of critical Health Authority (HA) compliance metrics reports

• Provide Expert Guidance to PDR Labelling (PDRL) and global affiliates ensuring all activities adhere to internal procedures international standards and HA regulations

• Identify and Mitigate Risks by proactively identifying existing or potential compliance issues/gaps evaluating the business impact and advising on corrective actions

• Support Audits and Inspections by acting as a key point of contact for the End-to-End (E2E) Labeling Global Process Owner (GPO) and contributing to inspection readiness activities

Who you are:

You are a dedicated compliance professional with practical regulatory knowledge and the leadership skills necessary to drive global execution within a complex matrix environment.

• Bachelors degree or equivalent in Life Sciences or a relevant field.

• Demonstrated experience in a Quality and Compliance area with practical knowledge of regulatory labelling processes.

• Strong understanding of pharmaceutical drug development processes and related workflows.

• Exceptional communication skills in English (written and spoken) are essential with additional languages being a definite asset.

• Proven ability to influence and negotiate effectively with stakeholders at all levels within a matrix environment through persuasion and networking

• Highly self-motivated organized and adept at prioritizing a high volume and varied workload autonomously

• Ability to apply in-depth knowledge and experience practically to complex situations serving as a trusted advisor to colleagues

In exchange we provide you with

• Development opportunities: Roche is rich in learning resources. We provide constant development opportunities free language courses & training the possibility of international assignments internal position changes and the chance to shape your own career.

• Excellent benefits & flexibility: competitive salary and cafeteria package annual bonus Private Medical Services Employee Assistance Program All You Can Move Sportpass coaching / mentoring opportunity buddy program team buildings holiday party.

• We also ensure flexibility to help you find your balance: home office is a common practice (2 office days/week on average and we provide fully remote working conditions within Hungary). We create the opportunity for freedom in working where your corporate and private life coexist in harmony.

• A global inclusive community where we learn from each other. At Roche we cooperate debate make decisions celebrate successes and have fun as a team. Thats what makes us Roche.

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A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.