Syner-G
Principal Regulatory Affairs Consultant
RemoteUnited States only
- Experience
- Principal
Salary not disclosed
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No BS summary
Principal Regulatory Affairs Consultant needed to guide clients through regulatory affairs, ensuring compliance and facilitating pharmaceutical product development and approval. Requires a Bachelor's degree in a scientific discipline, strong drug development background, and experience with INDs, NDAs, and BLAs. RAC certification or equivalent extensive experience is highly valued.
Core skills
drug developmentregulatory affairsFDA submissions
Required skills
biologicsclinical trialsINDsNDAsBLAsglobal submissionsMicrosoft Office SuiteTrackwiseVeevaICTDregulatory information management systems
Optional skills
MA degreeRAC Certification
Required languages
English
What you'll do
- 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.
What they require
- Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline
- Equivalent certifications or extensive experience in regulatory affairs are highly valued.
- 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.
- 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.
- 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.
Benefits
- 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
Syner-G is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.
Biopharma
Details
Visa sponsorshipNo
Salary not disclosed