Regulatory Affairs Manager
4 days ago
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.
The Regulatory Affairs Manager is responsible for independently leading the planning, submission and management of regulatory activities for a therapeutic area or for portfolio of strategic growth and new development products. This involves the development and implementation of regulatory strategies and the management of all regulatory submissions to lead to products with the earliest approvals and optimal labeling.
General:
- Overall responsibility for the independent efficient timely preparation of submission dossiers
- Contribute in evaluating the project priorities
- Independently lead evaluation and develop regulatory strategies (risks and opportunities) for new products and strategic growth products.
- Manage the Health Canada submission review process to achieve 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
- Fully 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 (eg Health Canada) and internal interfaces.
- Responsible for responding to queries from Health Canada.
- Represent the Regulatory Affairs function in cross-functional teams and initiatives and key country liaison for global regulatory strategic teams
- All other duties as assigned.
**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
855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Job Requisition ID: 255842
Location: Mississauga
Career Level: D - Professional (4-9 years)
Working time model: full-time
**North America Disclosure**
855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
**Notice on Fraudulent Job Offers**
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