Regulatory Affairs Project Leader

Work Your Magic with us Start your next chapter and join EMD Serono.

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.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The Regulatory Affairs Project Leader, reporting to the Director of Regulatory Affairs, is responsible for the planning, submission and management of regulatory activities for lifecycle products and strategic products. This involves the assisted leadership in regulatory strategy development and implementation / management of regulatory activities to achieve optimal submission outcomes.

Specific Responsibilities:

• Overall responsibility for the independent efficient timely preparation of submission dossiers
• Assisted leadership in the evaluation and development of key elements regarding regulatory strategies (risks and opportunities) for new products and strategic growth products.
• Manage the Health Canada submission review process to the earliest approval date with optimal labeling.
• Maintain registration compliance for approved products to support the ongoing marketing in Canada.
• Provide strategic advice to local partners on regulatory issues and strategies in cross-functional teams and initiatives. Build and maintain positive and productive relationships with internal interfaces
• Represent the Regulatory Affairs function in global regulatory strategic teams
• Responsible for the strategic creation, review, approval and maintenance of product labeling locally.
• Support clinical trial development activities for development products and pipeline development strategic evaluations
• Build and maintain positive and productive relationships with external contacts (e.g. Health Canada) and internal interfaces.
• Preparation or support of submissions including CTAs, NDS, S/NDS, NC, Level III and medical device licenses) Extensive contribution to the development of regulatory dossier documentation including autonomous critical analysis of data
• Fully responsible for the creation, review, approval and maintenance of product packaging artwork and Product Monographs to ensure compliance with the Canadian Food and Drugs Act and Regulations and internal standards.
• Significantly contribute to the management of Pre-submission Meeting activities with Health Canada.
• Review and approve promotional materials
• Maintain document management for all Regulatory files and correspondence within regulatory systems (e.g. Veeva)
• Contribute to the authoring and improvement of regulatory working instructions/flow processes/procedures including implementation of new regulatory requirements and policies
• Review and execute change control procedures that are performed at the local level
• Remain up to date on applicable laws, regulations, policies and guidelines including participation in the review / commenting of new requirements / guidelines consultations
• Alert Director to issues and potential problems, delays and/or deficiencies – making recommendations as appropriate.
• Position is on site with 5% travel 5%

Who You Are

Minimum Qualifications:

• 4+ years of work experience in Regulatory Affairs with biotechnology or pharmaceutical products
• Bachelor's degree

Preferred Qualifications:

• Advanced degree and post-graduate regulatory affairs certification are assets

• Demonstrated knowledge of the Canadian Food and Drugs Act and Regulations and relevant Health Canada policies and guidance documents.

• Solid understanding of product development, including pharmacology, toxicology, pharmacokinetics and clinical studies.
• Strong analytical skills with the ability to assess scientific data.
• Excellent communication skills, including written, verbal, and negotiation.
• Strong organizational and project management skills including the ability to manage multiple projects and priorities effectively.
• Strong organizational and project management skills including the ability to manage multiple projects and priorities effectively.
• Demonstrated interpersonal skills with respect to relationship building and teamwork.
• Demonstrated attention to detail
• Strong business acumen

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity