Regulatory Affairs Consultant Labelling - German Speaker m/f/d

Parexel; Schweiz; On-site; CHF 120,000 - 190,000; Full time

Job summary

Parexel International seeks an experienced Regulatory Affairs Consultant specializing in global labeling operations to shape labeling strategy across multiple markets and drive alignment of product information for a pharmaceutical portfolio. The role can be fully home-based or office-based.

Responsibilities include end-to-end labeling lifecycle management, preparation of regulatory submissions, and global collaboration with regional teams to ensure compliance across markets, including

Qualifications

• University degree in a life science discipline is required.
• 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 labelling 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.

Responsibilities

• Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance.
• Provide innovation and technical expertise for 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 labeling 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

Life science degree

Pharma/Biotech exp

Regulatory labeling experience

CCDS development

Swissmedic experience

Attention to detail

Leadership in matrix org

Global virtual teamwork

German & English fluency

Education

University degree in life science

Job description

We are seeking an experiencedRegulatory Affairs Consultantspecializing 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:

• Manageend-to-end labeling lifecycleincluding preliminary assessment, implementation, and post-approval maintenance

• Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meetcountry-specific regulatory requirements

• Execute labeling operations globally with precision and efficiency

• Participate in a'follow the sun' modelto ensure timely execution of labelling activities across time zones

• Prepare and review labelling documents for regulatory submissions and variations

• Maintain labeling databases and tracking systems

• Support global labelling harmonization initiatives

• Collaborate with regional regulatory teams to ensure compliance with local requirements

• Monitor regulatory intelligence related to labelling requirements

Skills and Experienced required for the role:

• University degree in a life science discipline

• A few yearsof experience in the biotech/pharmaceutical industry

• Labelling/regulatory experiencewith global responsibilities

• Experience with CCDS development and maintenance

• Strong understanding of regulatory labelling requirements across multiple markets

• Direct experience working with Swissmedic

• Excellent attention to detail and organizational skills

• Experience leading teams in amatrix organizationis expected

• Ability to work effectively in a global, virtual team environment

• Fluent in German and English, written and spoken