Syner-G BioPharma Group

Compliance

• 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.

Principal Regulatory Affairs Consultant

Payroll

• Primary ownership of hourly payroll processing, ensuring employees are paid accurately and on time
• Lend expertise to exempt payroll processing as needed
• Contribute to active ADP system projects designed to enhance operations
• Support global expansion efforts, including payroll operations in India
• Own end-to-end processing of hourly/non-exempt payroll cycles with a focus on timeliness, accuracy, and compliance
• Validate timekeeping data, resolve discrepancies, ensure proper documentation for each pay period
• Respond to hourly employee payroll inquiries professionally
• Provide backup support for salaried/exempt payroll processing
• Participate in ADP system configuration, testing, and optimization projects
• Support payroll-related workstreams tied to international expansion
• Maintain payroll records in accordance with federal, state, and local regulations
• Support year-end processing, tax filings, audits, and ad hoc reporting as requested

Payroll Analyst, Part-time

• Independently establish and execute sponsor oversight programs for clinical trials, including CRO qualification, ongoing performance monitoring, and risk-based quality oversight aligned with ICH E6(R3)
• Serve as the independent quality liaison between client sponsors and CROs, central labs, IRT/RTSM vendors, eCOA/ePRO providers, central imaging vendors, bioanalytical labs, and clinical supply CMOs
• Author and approve quality agreements with clinical vendors; review and approve clinical vendor SOPs, validation documentation, and oversight plans before study start
• Drive direction of the clinical quality function within client organizations — establish the quality oversight model, define escalation pathways, and align sponsor and vendor responsibilities
• Independently plan, conduct, and report GCP audits, including investigator site audits, CRO/vendor system audits, TMF audits, clinical database audits, and for-cause audits
• Lead pre-approval inspection (PAI) readiness and BIMO inspection preparation for sponsor clinical sites and key vendors; conduct mock inspections
• Author audit reports with defensible findings, regulatory citations, and severity classifications; track CAPA commitments to closure
• Build and maintain audit programs (risk-based audit plans, annual schedules, audit metrics) for client sponsors
• Review and approve clinical trial documents prior to use — protocols and amendments, ICFs, IB updates, monitoring plans, data management plans, statistical analysis plans, and clinical study reports — for GCP compliance and inspection-readiness
• Oversee TMF quality: review TMF completeness, contemporaneousness, and ALCOA+ compliance; advise on eTMF system configuration, indexing, and QC processes
• Approve essential documents for clinical trial start-up, including site selection packages, regulatory submissions support documentation, and IRB/EC correspondence
• Lead investigations into serious GCP issues including protocol deviations of significance, data integrity concerns, informed consent issues, IP accountability discrepancies, and suspected fraud or misconduct
• Author and approve CAPAs arising from audits, inspections, and quality events; ensure effectiveness checks are designed and executed
• Advise client sponsors on quality issue escalation, including determination of reportability to regulatory authorities and IRBs/ECs
• Provide quality input on regulatory submissions — IND, IMPD, CTA, NDA/BLA/MAA clinical modules — and represent the quality function during regulatory authority interactions
• Lead client inspection support during FDA BIMO, EMA, MHRA, or other Health Authority inspections of sponsors, sites, or vendors
• Maintain current knowledge of evolving GCP regulations and guidance (ICH E6(R3), ICH E8(R1), FDA decentralized clinical trial guidance, EU CTR, ICH E2A/E2B, 21 CFR Parts 11/50/54/56/312/812) and translate changes into actionable client recommendations
• Independently manage multiple concurrent client engagements; serve as the senior quality point of contact and represent Syner-G at client governance and steering committee meetings
• Expand existing accounts by identifying additional quality gaps and proposing scope extensions; support proposal development and SOW authorship for new GCP work
• Contribute to Syner-G's GCP service offering — develop reusable templates, audit checklists, training content, and thought-leadership materials.

Senior Consultant, Quality and Compliance

Project Manager

• Guide clients through the development, installation, and execution of comprehensive Operational and Business Excellence programs.
• Lead the delivery of a continuous improvement and organizational change framework.
• Serve as a strategic partner to client leadership, contributing to organizational goals and transformation roadmaps.
• Translate strategic objectives into actionable operational goals and structured improvement initiatives.
• Support the definition and evolution of organizational structures, roles, and governance models.

Lead Generation

• Conduct research and analysis to identify prospective accounts, key decision-makers, and emerging opportunities.
• Apply independent judgment in tailoring outreach strategies (email, telephone, and digital platforms) to effectively engage prospective clients.
• Collaborate with Marketing and Business Development Leads to design and refine campaign messaging that supports consultative selling.
• Assist in evaluating market trends and client challenges to recommend approaches for positioning Syner-G as a solution provider.
• Maintain Salesforce pipeline ownership at the entry level, ensuring accurate tracking, insight generation, and reporting of lead development activities.
• Summarize findings from outreach efforts and provide strategic recommendations to Business Development Leads to inform ongoing market engagement.
• Contribute to team discussions on lead generation tactics, offering insights from research and campaign outcomes.

Principal Regulatory Affairs Consultant

Payroll Analyst, Part-time

Senior Consultant, Quality and Compliance

Project Manager

Lead Generation Specialist