Syncromune

Role Description The Senior Manager of Regulatory Affairs will assist in all facets of the company’s Regulatory Affairs for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities. - Support the Senior Director of Regulatory Affairs to ensure adherence to appropriate regulations and standards. - Assist with determining regulatory requirements and prepare regulatory submission for all new/modified combination products, drugs, and medical devices. These submissions can include but not be limited to IND’s, BLA’s, meeting packages and expedited programs. - Participate in the coordination, preparation and timely submission of regulatory documents. - Ensure project teams prepare high quality international and domestic filings/registrations and responses to agency requests within established timelines. - Review submission packages for compliance with global regulations. - Write and edit technical documents. - Review and create standard operating procedures (SOPs). - Ensure regulatory documentation is maintained appropriately. - Interact with regulatory agencies as required. Qualifications - Bachelor’s Degree in Life Sciences, Engineering or related field. - Master’s degree preferred. - 5+ years in a regulatory capacity at a pharmaceutical company, biotech or CRO with 2+ years supporting oncology products. - High degree of understanding of regulatory requirements, how they operate, how to obtain updated information and where to obtain interpretations of them. - Experience in authoring part of regulatory documents such as M1, M2 of an IND, IND amendments, response to regulatory agency’s IR, expedited program applications. - Ability to inform and educate managers and department heads on regulations and policies that require compliance. - Ability to translate regulatory requirements into practical, workable plans. - Proficient with Microsoft Office Suite or similar software. - Proficient with applicable database and compliance software. - Must be able to juggle multiple and competing priorities. Requirements - Excellent organizational and project management skills. - Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed. - Excellent attention to detail. - Outstanding communication and collaboration skills within cross-functional teams and external organizations. - Ability to work in a fast-paced virtual environment. - Excellent verbal and writing skills. - Excellent analytical and problem-solving skills. - Excellent editing and proof-reading skills. - Self-directing, self-starting work ethic. - Excellent knowledge of the competitive environment for drugs in the oncology marketplace and in research and development pipelines. Working Conditions - The work environment shall be split between a virtual office environment and the Company headquarters in Fort Lauderdale, FL. - Domestic travel up to 10% of time. - Ability to lift up to 25 pounds. - Regularly required to stand, sit, talk, hear, and use hands. - Prolonged periods of sitting and standing. Benefits - Expected US salary range: $160,000-180,000. - This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.

Role Description The Director of Oligonucleotide Drug Substance Development and Manufacturing will lead and manage the development and manufacture of oligonucleotide drug substances across the product lifecycle, with a focus on technology transfer, scale-up, process characterization, and process validation at external Contract Development and Manufacturing Organizations (CDMOs). This role requires close collaboration with internal cross-functional teams and external partners to ensure the successful development, regulatory submission, and commercialization of therapeutic products. The ideal candidate will bring deep expertise in solid-phase synthesis, process development and optimization, process characterization and validation, and regulatory compliance for oligonucleotide therapeutics. The role interfaces extensively with drug product development, analytical development, manufacturing operations, quality assurance, and regulatory affairs. Qualifications - Master's or Ph.D. degree in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related field. - 8 years minimum experience in the pharmaceutical or biotechnology industry in the field of oligonucleotides solid phase synthesis process development and manufacturing. - Demonstrated experience in process development, scale-up, technology transfer, and process validation for oligonucleotides drug substances. - Extensive knowledge of cGMP/GLP ICH and FDA guidelines. - Experience in IND and NDA or BLA submissions. - Experience managing CROs and CDMOs. - Proven track record in authoring technical and scientific documents for regulatory submissions. - Expert knowledge of advanced principles, concepts, and theory related to product and process development. - Candidates proficient in both English and Mandarin are highly encouraged to apply. - Excellent leadership, organizational, and project management skills. - Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed. - Outstanding communication and collaboration skills within cross-functional teams and external organizations. - Ability to work in a fast-paced virtual environment. - Flexibility to travel domestically and internationally as required. - Excellent leadership, organizational, and project management skills. Requirements - Lead the development and optimization of scalable, robust manufacturing processes for oligonucleotide drug substances, ensuring efficiency, yield, purity, and product quality. - Apply principles of physical chemistry, process engineering, and analytical chemistry to design and control manufacturing processes that result in high purity drug substance. - Implement Quality by Design (QbD) principles and ensure compliance with current Good Manufacturing Practices (cGMP). - Partner closely with Quality to ensure adherence to applicable GxP requirements. - Prepare technical development reports and author, review, and approve relevant sections of INDs, NDAs/BLAs, briefing packages, and other regulatory submissions. - Develop and manage timelines and budgets for process development, scale-up, technology transfer, and manufacturing to support clinical supply and registration milestones. - Participate in the selection, qualification, and technical oversight of CDMOs and other external partners, including CROs and consultants. - Lead technology transfer activities to and from CDMOs, ensuring effective knowledge transfer and smooth execution. - Plan and oversee scale-up activities to support clinical, registration, and commercial manufacturing needs. - Develop risk-based strategies for technical oversight based on product lifecycle stage, process complexity, and CDMO capabilities. - Design and execute process characterization studies, including DoE-based approaches, to identify critical process parameters and establish control strategies. - Develop and oversee process validation strategies, including drafting and approving protocols and reports to support regulatory compliance. - Define in-process controls, critical quality attributes, and stability programs; oversee early GMP manufacturing and characterization of clinical lots. - Plan and supervise late-stage drug substance manufacturing activities in support of drug product manufacturing, co-formulations, registration, and commercial supply. - Collaborate closely with Analytical Development, Manufacturing, QA, Regulatory Affairs, Clinical Development, and Program Management, as well as external partners. - Manage multiple development and manufacturing programs, contributing to project prioritization, timelines, and budget control. - Oversee GMP sample handling, testing, release, stability programs, data trending, and OOE/OOS investigations in collaboration with Analytical and QC teams. - Support generation and approval of Certificates of Analysis for clinical supply materials. - Management of oligonucleotides drug substance inventory to satisfy the demand of drug product manufacturing necessary for clinical development. - Monitor oligonucleotides drug substance stability and managing drug substance retesting and expiration extension programs. - Direct internal and external GMP manufacture and supply of oligonucleotides drug substance to ensure timely supply of materials needed for clinical trials. - Manage drug substance and raw material specifications and stability protocols. - Ensure compliance with QbD principles, cGMP, and applicable GxP requirements in partnership with Quality. - Support regulatory interactions, including responses to agency questions and participation in regulatory meetings and pre-approval inspections as needed. Benefits - Expected US salary range: $235,000-$255,000. - This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans. Company Description Syncromune is an Equal Opportunity Employer. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.