Syner-G - Principal Regulatory Affairs Consultant

Remote - USA *2mo ago

Remote Principal NA Medical Devices Clinical Research Principal Regulatory Affairs Specialist Microsoft Office Close Clinical Trials Clinical Documentation Documentation

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. • 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. • ESSENTIAL FUNCTIONS: • Physical Demands:The physical demands described here represent the requirements for successful performance of the essential functions. Reasonable accommodations may be made for individuals with disabilities. While performing job duties, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The role requires frequent walking and sitting, and occasional lifting of objects up to 25 pounds. Vision requirements include close vision and the ability to adjust focus. • Work Environment:The work environment characteristics include a typical office environment with moderate noise levels, bright lighting, and an indoor temperate setting. • TOTAL REWARDS PROGRAM:We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture. This includes a competitive base salary, annual incentive plan, comprehensive benefits, and ongoing recognition and career development opportunities. Employees benefit from flexible paid time off, company-paid holidays, flexible working hours, and remote work options for most roles. Office locations are available in Greater Boston; San Diego, CA; Boulder, CO; and India.

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.

Benefits

• Syner-G is unable to sponsor or take over sponsorship of employment visas at this time. • LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s 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. • LEGAL STATEMENT: