Senior Regulatory Affairs Associate

Posté 25 juil. 2022

Mississauga, Ontario - Canada

Demander un identifiant 252490

Détails

 

A career with EMD Serono is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

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.

 


Your Role:

The Senior Regulatory Affairs Associate, is responsible for the planning, submission and management of regulatory activities for lifecycle and strategic products. This involves participation in the development and implementation of regulatory strategies.

 

Responsibilities
• Efficient and timely dossier preparation and submission for dossiers across therapeutic areas. Contribute to regulatory strategy development and execute regulatory activities with guidance for lifecycle and strategic products in accordance with corporate priorities
• Maintain registration compliance for approved products to support the ongoing marketing in Canada
• Represent the Regulatory Affairs function in actively contributing to cross-functional teams and initiatives
• Manage the Health Canada submission review process with manager to achieve the earliest approval date with optimal labeling for lifecycle and strategic products and key strategic projects
• Responsible for the creation, review, approval and maintenance of product labeling
• Responsible for responding to queries from Health Canada regarding the submissions with guidance from management

• Maintain registration compliance for approved products to support the ongoing marketing in Canada
• Participate in global regulatory strategic teams


• Perform regulatory affairs activities associated with development of investigational new drugs, medical devices, registration of new products/indications, CMC changes and support of marketed products in assigned Therapeutic Areas.
• Responsible for the guided preparation of submissions including S/NDS, NC, Level III and medical device licences and NDS support
• Actively participate in the generation, elaboration and review of agreed elements of the core registration file under guidance to ensure compliance with local regulations and compatibility with Corporate and local Canadian business needs
• 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,regulations and internal standards.
• Participate in Pre-submission meetings with Health Canada
• Contribute to regulatory strategy development and provide regulatory advice for Canadian registrations and functional support.
• Remain up-to-date on applicable laws, regulations and guidance and participate in the review and support the implementation of the new requirements
• Review and approve promotional material and programs
• Perform document management for all Regulatory files and correspondence (paper and electronic), including maintaining internal submission tracking and product databases.
• Contribute to the improvement and generation of regulatory working instructions/flow processes/procedures as required
• Review and approval of Change Control Procedures that are performed at the local level.

 

 

Who You Are:

Basic Qualifications:
• Minimum 3+ years experience in Canadian Regulatory Affairs in the biotechnology or pharmaceutical industry or at Health Canada
• University degree in a Life Science or a relevant scientific discipline. Advanced degree and post-graduate regulatory affairs certification are assets.

 

Preferred Qualifications:

• Experience with biological and chemical submissions is a strong asset.
• 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.
• Demonstrated interpersonal skills with respect to relationship building and teamwork.
• Demonstrated attention to detail, balanced with a capable understanding of business objectives.
• Experience with Microsoft Office (Word, Excel, PowerPoint) and Adobe.


 

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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
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

 

Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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