Regulatory Affairs Specialist

Regulatory Affairs Specialist

Lonza

Bornem, Belgium

Key Responsibilities:

• Capture regulatory evolution, documented via a pragmatic impact assessments and centralized in an overview database
• Translate applicable regulations or guidelines into comprehensive action plans and ensure proper implementation
• Support internal EMEA partners (sales/marketing/commercial/logistics) with any regulatory changes, by providing training sessions on any (regulatory) topic and engaging in discussions to ensure appropriate implementation in case of regulatory impact
• Actively support customers and authority requests with the aim to increase Customer Satisfaction and regulatory compliance
• Support marketing, R&D, Lonza BU, and working groups from customers in ad hoc projects, in relation to market growth and innovation initiatives by preparing EMEA regulatory assessments for relevant regulatory topics of interest. Where vital, engage in discussions with the appropriate trade organizations to support innovation
• Support the logistics team by determining the correct export / import certificate to be used and by reviewing and signing off on export certificates issued in the context of shipping goods from EMEA to countries outside the EU. Where needed, liaise with local and foreign Authorities to come to an agreement
• Participate to relevant and value adding industry conferences as well as required external and internal regulatory expert networks or trade associations

Key requirements:

• Bachelors or Master’s degree in life sciences area or equivalent experience in a highly regulated field
• Previous experience with the GMP environment
• Proficiency in English

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