Associate Principal Scientist

Location: Gaithersburg, MD
Date Posted: 03-15-2018
The role 

• Point of contact for Regulatory Affairs towards the process for the creation, approval, and implementation of commercial printed labeling in collaboration with various functions 
• Coordinates cross-functional teams in the development and lifetime maintenance of the US and/or EU (centralized) packaging component labeling for all commercial products 
• Provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design 
• Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate 
• Interact with Marketing Company colleagues regarding artworks as appropriate 
• Process and prepare US Final Printed Labeling and required EU specimens for submission 
• Assist Global Labeling team in resolution of labeling issues as needed 
• Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function 
• Assist in other regulatory activities as required 

Minimum experience 
• University Degree in Science or related discipline 
• 3 to 5 years pharmaceutical experience, preferably regulatory experience, preferably working with labeling 
• Knowledge of labeling regulations and guidances 
• Keen attention to detail and accuracy 
• Excellent verbal and written communication skills in English is necessary. 
Experience in packaging labeling development is highly appreciated but is not a requirement. 
Skills and Capabilities 

• Ability to work collaboratively 
• Building Relationships (works well across formal and informal networks) 
• Negotiation Skills (good listener; able to build a consensus) 
• Critical Information Seeking (works well across formal and informal networks) 
• Rational Persuasion (able to distil an issue to its key components and suggest solutions) 
• Interpersonal Awareness (aware of how actions affect other people) 
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures. 
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
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