Principal Regulatory Affairs Consultant

About the role

A career at Syner-G is life-enhancing. We enable our people to build impactful careers in the biopharma industry, accelerating breakthrough science and delivering life-changing therapies. Our diverse projects span from early-stage drug development to commercialization, and we support organizations through every phase of the drug approval process. Our mission is to foster a positive and engaging work environment, rewarding our employees with a variety of benefits including financial rewards, career growth, and innovative solutions.

Key Responsibilities

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients.
• Handle FDA Type A, Type B, and Type C meetings.
• Engage in all phases of drug development, from early-stage to post-registration.
• Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams.
• Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality.
• Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines.
• Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements.
• Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement.
• Serve as the main point of contact for clients, ensuring effective communication and regulatory support.
• Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes.
• Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions.
• Partner with clients on Non-Clinical/Clinical strategy and submissions.
• Evaluate proposed manufacturing and quality changes for impact on existing registrations.
• Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities.

Requirements

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred.
• RAC Certification is a significant advantage; equivalent certifications or extensive experience in regulatory affairs are highly valued.

Knowledge, Skills, and Abilities

• Strong background in drug development, biologics, and clinical trials.
• Proven experience in handling INDs, NDAs, BLAs, and global submissions.
• Demonstrated ability to adapt to client needs, providing strategic advice and tactical support across various therapeutic areas.
• Attended relevant conferences, training, and job shadowing opportunities.
• Proficient in Microsoft Office Suite and industry-specific software tools such as Trackwise, Veeva, and ICTD.
• Strong understanding of drug development, manufacturing, and clinical development processes.
• Experience in authoring and managing Non-Clinical/Clinical Medical Device and FDA sections for regulatory submissions.
• Ability to evaluate manufacturing and quality changes for regulatory impact.
• Demonstrated proficiency in regulatory information management systems and tools.

Total Rewards Program

• Competitive base salary.
• Annual incentive plan.
• Comprehensive benefits.
• Ongoing recognition and career development opportunities.
• Flexible paid time off.
• Company-paid holidays.
• Flexible working hours.
• Remote work options for most roles.

Work Environment

The work environment is a typical office setting with moderate noise levels, bright lighting, and an indoor temperate setting. Physical demands include regular use of a computer keyboard and mouse, reaching with hands and arms, talking and listening, frequent walking and sitting, and occasional lifting up to 25 pounds.

Legal Statement

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions are made without regard to race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.