Senior Regulatory Affairs Consultant - Labelling Strategy (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Ireland, Czechia, Italy, Croatia, Serbia, Oregon (USA) When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About the Role

As a Labelling Strategy Regulatory Affairs Senior Consultant you will act as the principal labeling strategist within Global Regulatory Affairs (GRA). You will drive the development of Labeling strategies, the creation and maintenance of the development Company Core Data Sheet (dCCDS), the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio, as assigned, to ensure optimal alignment of the company position, labeling requirements, and commercial opportunities. As a seasoned expert, provides strategic input into the GRA Therapeutic Area Team from a labeling perspective. You will ensure that the company core product claims across products with the same active substance are globally aligned and leads the Global Labeling Committee assessment of proposed changes to the dCCDS/CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC. The role can be home or office based in various European locations.

Key Responsibilities

• Generates and maintains the development Company Core Data Sheet (dCCDS), the Company Core Data Sheet (CCDS), the USPI and the EU SmPC as assigned. Delivers the labeling strategy to early development activities to ensure consideration of labeling in claims development programs. Ensures that the labeling strategy is aligned with the overall product regulatory, registration and development strategy.
• Contributes from the labeling perspective/labeling environment to Clinical Study designs, protocols, Investigator Brochures and Briefing Books.
• For the dCCDS/CCDS, leads the interactions with relevant Subject Matter Experts (SMEs) and stakeholders, such as Global Clinical Safety and Pharmacovigilance (GCSP), Global Clinical Development (GCD), Global Regulatory Affairs (GRA) and Commercial Development and Operations (CDO).
• For the USPI and EU SmPC, collaborates with the Regional Regulatory Therapeutic Area leads the review of these labels and respective, interaction with relevant SMEs.
• Ensures consistent communication to the Global Labeling Operation Managers, regions and countries regarding new and updated CCDSs for Therapeutic Area.
• Leads the assessment and, as necessary, Global Labeling Committee (GLC) review of proposed exceptions between the CCDS and the USPI and/or SmPC utilizing established departmental processes and maintaining compliance. Escalates differences and compliance issues to the Director, Global Labeling Strategy and/or labeling governance bodies as necessary.
• Represents Global Labeling on respective product Global Regulatory Affairs Strategy Teams (GRASTs), GRA Therapeutic Area (TA) teams and ensures that an effective communication pathway exists between the GRAST, TA teams and Global Labeling.
• Remains up to date with the global labeling requirements and expectations.
• Represents Global Labeling in internal and external meetings.
• Builds effective, cross-functional networks with GRA (regional and global) as well as across functions within R&D and Commercial Development.

Skills and Experience required for the role:

• University degree in Life Sciences or related Pharmaceutical field
• Minimum of 10 years of biotech/pharmaceutical industry experience. This is inclusive of 6 years of labeling/regulatory experience combined with other global responsibility.
• Knowledge and understanding of principles of regulatory relevant to drug development, global labeling and post-marketing requirements.
• Strong scientific background and ability to understand and interpret scientific documents and concept with the ability to translate them into labeling content.
• Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions.
• Proficient regulatory and drug/biologic development (pre-clinical to post-clinical) knowledge including an understanding of broad scientific concepts within labeling and their implications across the organization and globally.
• Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact.
• Attention to detail, coupled with the ability to think strategically.
• Fluency in English (verbal and written).

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