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Senior Regulatory Affairs Specialist
3 months ago
At Bayer, we are innovators committed to addressing the world's most pressing challenges, striving for a reality where 'Health for all, Hunger for none' is achievable. Our approach is fueled by energy, curiosity, and unwavering dedication, as we continuously learn from diverse perspectives, expand our thinking, enhance our capabilities, and redefine what is possible. Joining us means becoming part of a vibrant community of brilliant minds dedicated to making a meaningful impact.
Position Overview: Senior Regulatory Affairs Specialist
The Regulatory Affairs team within the Pharmaceutical Division is focused on the registration of new products and ensuring compliance with existing products in accordance with Federal and Provincial Regulations. This department is pivotal in identifying solutions that align with commercial goals while addressing issues that may impact business operations and patient care.
Bayer Inc.'s Pharmaceutical Division is currently undergoing a significant transformation in our operational model and customer engagement strategies to enhance service delivery to our patients and clients, ultimately achieving 'Health for All.'
Reporting to the Head of Regulatory Affairs, the Senior Regulatory Affairs Specialist will play a crucial role in developing regulatory strategies and executing activities to secure and maintain clinical trial and drug/device registrations in adherence to all Canadian regulatory standards. This role involves managing assigned products to fulfill the objectives of the Regulatory Affairs team, including the execution of complex regulatory submissions. The Specialist will also engage with external stakeholders and cultivate strong collaborative relationships with both local and global teams in managing regulatory activities.
Key Responsibilities:
- Oversee the management of assigned products and projects.
- Contribute significantly to the development and exploration of efficient and innovative submission strategies, carefully evaluating and summarizing scientific, clinical, and technical information.
- Prepare high-quality submissions and implement complex regulatory submission strategies for new product and clinical trial registrations, ensuring ongoing regulatory compliance for product-related changes.
- Coordinate labeling changes and quality management activities in collaboration with local and global teams.
- Establish and maintain effective communication with Canadian Health Authorities and other external stakeholders, primarily regarding regulatory submission activities.
- Participate in the management and execution of meetings with Health Canada throughout the drug development and filing processes.
- Collaborate with local and global partners on cross-functional teams, providing regulatory insights for product strategy development and resolution of product-related challenges.
- Assess the impact of changes in Chemistry, Manufacturing, and Controls (CMC) or clinical drug development.
- Review clinical trial product labeling and materials for marketed products to ensure compliance with corporate and regulatory standards.
- Perform additional Regulatory Affairs duties as necessary, potentially across specific Therapeutic Areas.
- Review and approve promotional materials and product labeling for regulatory compliance, submitting to pre-clearance agencies as required.
- Develop and maintain departmental procedures to ensure adherence to the Food & Drugs Act, Health Canada Regulations, and other relevant industry standards, while aligning with global quality system requirements.
Qualifications:
- B.Sc. (required) or M.Sc. (preferred) in Pharmacology, Chemistry, Biological Sciences, PharmD, or equivalent.
- Understanding of the Food and Drugs Act and associated regulations.
- Proven success in a regulatory environment, including experience leading regulatory submission teams and knowledge of drug development processes.
- A minimum of 2 years of experience in Regulatory Affairs.
- Experience across multiple Therapeutic Areas.
- Strong analytical abilities to evaluate scientific data.
- Proficient computer skills; excellent written, verbal, organizational, and negotiation skills.
- Exemplifies and embodies the Visionary, Architect, Coaching, and Catalyst (VACC) capabilities.
What We Offer:
- Competitive compensation and benefits package.
- A collaborative, diverse, and inclusive workplace culture.
- Opportunities for career development and global engagement.
- Work-life balance programs, including flexible hours, employee discounts, volunteer days, wellness initiatives, and other employee offerings.
Bayer is dedicated to fostering a culture of Inclusion and Diversity. We value and encourage the unique differences of our employees, recognizing that their diverse experiences, knowledge, and capabilities are our greatest assets. The collective contributions of our workforce shape our culture, reputation, and the values and purpose of Bayer.
