Regulatory Affairs Consultant – Labelling Strategy
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Job Description
Regulatory Affairs Consultant developing labeling strategies for pharmaceutical products globally. Collaborating with cross-functional teams to ensure compliance and alignment with global regulations.
Responsibilities:
- Act as a labeling strategist within Global Regulatory Affairs (GRA)
- Drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio
- Ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area
- Manage the exception process between the CCDS and the USPI and EU SmPC
- Collaborate with relevant Subject Matter Experts and stakeholders
- Ensure consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products
- Maintain compliance by leading the assessment and Global Labeling Committee review of proposed exceptions
- Represent Global Labeling on respective product Global Regulatory Affairs Strategy Teams
Requirements:
- University degree in Life Sciences or related Pharmaceutical field
- Minimum of 7 years of biotech/pharmaceutical industry experience, including 4 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
- Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions
- 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)
Benefits:
- Health insurance
- Professional development opportunities
- Flexible working arrangements
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