Regulatory Affairs Consultant - Labelling
Parexel International, Indiana, Pennsylvania, us, 15705
We are seeking an experienced Regulatory Affairs Consultant specializing in global labelling operations to join our growing Regulatory Affairs team. This role offers the opportunity to shape labelling strategy across multiple markets and drive global alignment of product information for pharmaceutical portfolio of our clients.
The role can be fully home based or office based.
Key Responsibilities:
Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance
Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements
Execute labeling operations globally with precision and efficiency
Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones
Prepare and review labeling documents for regulatory submissions and variations
Maintain labeling databases and tracking systems
Support global labeling harmonization initiatives
Collaborate with regional regulatory teams to ensure compliance with local requirements
Monitor regulatory intelligence related to labeling requirements
Skills and Experience required for the role:
University degree in a life science discipline
A few years of experience in the biotech/pharmaceutical industry
Labelling/regulatory experience with global responsibilities
Experience with CCDS development and maintenance
Strong understanding of regulatory labeling requirements across multiple markets
Direct experience working with Swissmedic
Excellent attention to detail and organizational skills
Experience leading teams in a matrix organization is expected
Ability to work effectively in a global, virtual team environment
Fluent in German and English, written and spoken
#J-18808-Ljbffr
The role can be fully home based or office based.
Key Responsibilities:
Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance
Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements
Execute labeling operations globally with precision and efficiency
Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones
Prepare and review labeling documents for regulatory submissions and variations
Maintain labeling databases and tracking systems
Support global labeling harmonization initiatives
Collaborate with regional regulatory teams to ensure compliance with local requirements
Monitor regulatory intelligence related to labeling requirements
Skills and Experience required for the role:
University degree in a life science discipline
A few years of experience in the biotech/pharmaceutical industry
Labelling/regulatory experience with global responsibilities
Experience with CCDS development and maintenance
Strong understanding of regulatory labeling requirements across multiple markets
Direct experience working with Swissmedic
Excellent attention to detail and organizational skills
Experience leading teams in a matrix organization is expected
Ability to work effectively in a global, virtual team environment
Fluent in German and English, written and spoken
#J-18808-Ljbffr