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.

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 structureComprehensive health, dental, and vision insuranceRetirement savings plan with company matchProfessional development opportunitiesFlexible 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.)