Regulatory Affairs Director

26 Oct, 2020


Regulatory Affairs Director

GE Healthcare
Marlborough, MA

We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world’s toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people’s lives. With every weld, every sale, and every code we write we keep the world in motion. It’s time to stop dreaming about the future; let’s build it together.

This position primarily provides regulatory direction and guidance to the business regarding regulatory requirements for US drug product development. The position will also support US marketed product regulatory affairs and regulatory submissions. Regulatory activities covered by this position include preparing regulatory strategies, IND, NDA, ANDA, and DMF drug product submissions, postmarket reporting, marketed product submissions, and regulatory intelligence as applicable.Job Description

Essential Responsibilities :
• Provides regulatory input for product development to ensure compliance to regulatory requirements for the US market
• Ensures that highly effective proactive strategic US RA input is provided to Global Regulatory plans
• Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions
• Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions and submits premarket submissions to FDA, as per business timelines
• Prepares and files regulatory submissions to ensure continued market access, per business direction
• Assesses changes in existing products to determine the need for supplemental applications
• Contributes to writing and editing technical documents and responses to FDA inquiry
• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
• Understands and applies regulatory requirements and their impacts for submissions
• Ensures compliance with pre- and post-market product approval requirements
• Supports regulatory inspections as required
• Performs a broad variety of tasks in support of product and process design and other tasks as assigned by the departmental manager
• Supports and encourages a collaborative, open and team based culture across own organization, the larger Regulatory Affairs organization, and all of GE Healthcare
• Serves as an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements
• Interacts with and represents GE Healthcare in interactions with FDA

Quality Specific Goals:
• Aware of and comply with the GE Healthcare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type / position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required

Qualifications/Requirements :
• Bachelor’s Degree and a minimum of 7 years work experience in the pharmaceutical industry
• Minimum of 5 years’ experience of US regulatory affairs and FDA interactions
• Experience working globally and across different cultures
• Ability to communicate effectively in English (both written and verbal).
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation and database applications

This role can be based anywhere in the US but we prefer CST or EST time zone.

Desired Characteristics :
• 15 years’ experience in pharmaceutical US Regulatory Affairs
• Assertive and willing to make decisions
• Ability to juggle and prioritize multiple competing priorities and complete tasks on-time
• Ability to assign clear priorities
• Tenacious and delivery focused
• Ability to make sound business judgments

Additional Eligibility Qualifications :
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

Relocation Assistance Provided: No

About Us
GE (NYSE:GE) rises to the challenge of building a world that works. For more than 125 years, GE has invented the future of industry, and today the company’s dedicated team, leading technology, and global reach and capabilities help the world work more efficiently, reliably, and safely. GE’s people are diverse and dedicated, operating with the highest level of integrity and focus to fulfill GE’s mission and deliver for its customers.
Learn more here

Job posted: 2020-10-26