Regulatory Affairs Manager - Labeling Location: Remote – Eastern Time zone Job Category Regulatory Affairs
The company
My client is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our customers. The company was established in the US in 1995, and has grown to more than 2,000 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.
Essential Duties and Responsibilities
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Lead creation and maintenance of Company Core Data Sheets (CCDS or CDS), Company Core Safety Information (CCSI or CSI), Product Inserts (PI), Summary of Product Characteristics (SmPC), and Reference Safety Information (RSI) for assigned drug/therapeutic/pharmaceutical products
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Drive regulatory cross function efforts to achieve Labeling end-to-end compliance
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Manage the change and facilitate tracking through to implementation the labeling content
into global and country-specific labeling
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Lead global labeling change committees.
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Provide strategic input to internal partners and manage feedback from global stakeholders on labeling issues.
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Plan and manage complex projects
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Represent or lead the RA function on assigned cross-functional project teams
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Monitor, evaluate, and interpret all new and existing applicable regulatory requirements related to assigned product portfolio labeling
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Assess and communicate impact of new regulations
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Align labeling team objectives with global regulatory and business objectives
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Deliver inputs in response to Quality initiatives or audit and regulatory authority questions associated with responsibilities
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Identify & prioritize key areas of risk, and develop & implement appropriate mitigation plans
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May provide direct supervision of individuals
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Perform gap analysis on regulatory documentation and propose solutions. Identify areas
for improvement
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Develop and document sound regulatory decisions and justification
Qualifications
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Scientific knowledge
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Ability to multitask and prioritize
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Ability to work effectively in multinational/multicultural environment
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Sound basis of Regulatory knowledge, including drugs/biologics/pharm/therapeutics
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Management skills
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Ability to manage complex projects and timelines in a matrix team environment
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Strong interpersonal, communication and presentation skills
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Demonstrated interpersonal skills including strong negotiation skills
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Technical and management skills
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Ability to lead and coach others
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Ability to independently identify compliance risks and escalate when necessary
Education
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Bachelor’s degree or country equivalent in a scientific discipline, pharmacy, biochemistry or similar preferred
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Advanced degree will be an advantage
Experience
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Minimum of 5 years of regulatory experience in RA or related field, including managing people or projects
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Minimum 2 years of creating and/or managing labeling for pharmaceutical products