Regulatory Expert CDMO

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

As an Expert in Regulatory Management, you will work with all counterparts to align on regulatory strategy. This will be in a global regulatory team that shares systems and processes. You will collaborate with internal experts within the quality, technical and business areas across the organization to gather data and support efforts. You interpret and transfer country regulatory requirements into CMC/Technical requirements; for providing prospective advice to the interdisciplinary CMC team; and for identifying potential pharmaceutical issues and risks. You will contribute to risk mitigation and problem solving in close collaboration with concerned interface functions. You will support our customers in their regulatory activities.

• The Global Regulatory team will:
• Discuss and develop a regulatory strategy
• Ensure execution of regulatory objectives in a timely fashion
• Working with site colleagues and business to ensure specific processes and strategy goals are aligned such as:
• Registering dossiers such as DMFs, ASMFs, CEPs, BBMFs, CN-DMFs and other master file documents (globally).
• Create, maintain, responses to deficiencies and assess changes impacting submitted dossiers through change control process.
• Country-specific health authority responses and impact of overall strategy for dossiers.
• Support and lead Regulatory and client audit responses and reports relate to regulatory filing, to ensure their timely written submissions.
• Participate in Change Control procedures according to the current pharmaceutical requirements and systems and processes for CMC Dossier approvals.
• Ensure that relevant changes to product registrations and listings are properly notified to the relevant authorities.

Customer Support:

• Work directly with customers in a consultative role to support customer’s regulatory drug substance sections for filings and submissions.
• Prepare and review documents for submission to regulatory agencies in compliance with requirements. Support provisions of responses to customer regulatory inquiries.
• Regulatory department tracking databases for planning, scheduling, submissions, and action dates, and overall project management.
• Create policies and operating procedures to strengthen Regulatory compliance against FDA and EMA standards.
• Supports the issuance of Letters of Authorization (LOA) and regulatory statements for client filings.
• Authority notifications, registrations, and licenses for registration purposes of pharmaceutical materials (when applicable).

Location: St. Louis, MO - Hybrid

Who you are:

Minimum Qualifications:

• Bachelor or Master level of education in pharmacy or life sciences with a strong emphasis in chemistry, biology or related field.
• Minimum of 5 years of relevant industry experience and/or regulatory affairs related to biopharmaceutical active ingredients, pharmaceutical substances, and process materials.

Preferred Qualifications:

• Knowledgeable of US FDA and EU drug regulations, specifically for submissions in CTD format for drug products, including IND submissions
• Knowledge of regulatory landscape of other important regions, e.g., in Asia
• Experience in e-submission tools is welcome.
• Proficient in MS Office Software (Word, Excel, PowerPoint) and ERP Systems such as Oracle or SAP
• Demonstrate good communication & project management skills. Work successfully within a multidisciplinary international team.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html