Regulatory Project Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our collaborative team at Thermo Fisher Scientific as a Senior Manager of Regulatory Affairs, where you'll have a crucial role in ensuring global regulatory compliance and leading strategic initiatives. You'll guide regulatory activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics. Working closely with cross-functional teams, you'll develop and implement regulatory strategies to support product development, registration, and lifecycle management. This position offers the opportunity to make a significant impact on bringing innovative scientific solutions to market while ensuring compliance with evolving global regulations.

In this role, you'll provide strategic regulatory guidance, lead submission preparations, interact with regulatory authorities, and manage regulatory intelligence activities. You'll collaborate with Quality, R&D, Marketing, and other stakeholders to ensure regulatory requirements are met throughout product development and commercialization. This position combines technical expertise with leadership skills to drive regulatory excellence across the organization.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in pharmaceutical, medical device, or diagnostics industry
• Preferred Fields of Study: Life Sciences, Chemistry, Engineering, Pharmacy or related scientific field
• Regulatory affairs certifications beneficial
• Comprehensive knowledge of global regulations and guidelines (FDA, EMA, PMDA, NMPA)
• Demonstrated expertise in regulatory strategy development and implementation
• Strong experience with regulatory submissions (IND, BLA, NDA, 510(k), CE marking)
• Proven track record of successful interactions with regulatory authorities
• Experience managing and developing regulatory affairs staff
• Advanced understanding of GMP/QMS requirements and compliance
• Excellent project management and organizational skills
• Strong analytical and problem-solving capabilities
• Superior written and verbal communication skills
• Ability to influence and collaborate across all organizational levels
• Proficiency with regulatory information management systems
• Proven ability to manage multiple projects simultaneously

• Available for approximately 20% travel

• Business-level English proficiency required, additional languages beneficial

Originally posted on Himalayas