Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Thermo Fisher is committed to upholding the highest standards of quality, safety, and compliance in bringing innovative products to market. Our Regulatory Affairs team plays a vital role in ensuring compliance with the ever-evolving global regulations governing our industries.
Job Description:
We are seeking a Sr. Manager, Regulatory Affairs with experience in working with US Institutional Review Boards (IRBs) and Canadian Ethics Committees (ECs). The ideal candidate will have a consistent track record of providing strategic regulatory guidance and leading a team to ensure compliance with regulatory requirements.
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Key Responsibilities:
- Develop and implement regulatory strategies for product approvals and compliance in the US and Canada, considering the unique requirements of US IRBs and Canadian ECs.
- Lead, mentor, and manage a team of regulatory affairs professionals, fostering a collaborative and high-performance culture.
- Lead all aspects of the preparation, review, and submission of regulatory documents, including Investigational New Drug (IND) applications and other regulatory filings to US and Canadian regulatory authorities.
- Collaborate with cross-functional teams, including clinical, strategic consulting and other departments, to ensure alignment on regulatory strategies and objectives.
- Supervise and interpret regulatory changes, trends, and developments in the US and Canada, and update regulatory strategies accordingly.
- Address and resolve regulatory issues and provide regulatory advice on sophisticated topics for which there may not be clear or specific guidelines.
- Develop and implement training programs to enhance the regulatory knowledge and skills of the team and other collaborators.
Qualifications:
- Education: Bachelor's degree in a scientific discipline is required. Advanced degree (Master's, PhD, or equivalent) preferred.
- Experience: Minimum of 7-10 years of regulatory affairs experience, with significant experience in looking after US IRBs and Canadian ECs.
- Shown experience in managing and leading a team of regulatory professionals.
- In-depth knowledge of US and Canadian regulatory requirements, guidelines, and submission processes.
Skills and Abilities:
- Detail-oriented, proactive, and able to work optimally in a fast-paced and multifaceted environment.
- Strong analytical, organizational, and project management skills. Excellent written and verbal communication skills.
Benefits:
- Competitive salary and bonus structure
- Comprehensive health, dental, and vision insurance
- Retirement savings plan with company match
- Professional development opportunities
- Flexible work arrangements
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)