{"id":768383,"url":"https://alion.io/job/genefab-senior-specialist-regulatory-programs-part-time","title":"Senior Specialist, Regulatory Programs (Part-Time)","company":{"id":674418,"name":"GeneFab","domain":"genefab.com","url":"https://alion.io/company/genefab","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"part_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Alameda, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":85,"max":95,"currency":"USD","period":"hour","gross":null,"usd_annual":190000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-11T00:00:06Z","employer_posted_date":"2026-08-11","last_verified_at":"2026-11-10T15:14:01Z","board_verified":true,"closed_at":null,"days_open":91,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":91},"description":"We are seeking an experienced and dynamic Quality Regulatory Program Manager to lead our quality assurance regulatory initiatives. As the Program Manager, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards in manufacturing processes, and driving continuous improvement initiatives to enhance product quality and patient safety. This key role will develop and implement regulatory strategies leading to successful registration and life-cycle management of complex products serving patients and clients. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.\nResponsibilities\nPlan, prepare, and manage submissions to HAs including, INDs, NDA/BLA regulatory filings in strong collaboration with GeneFab’sclients.\n\nParticipate in regulatory interactions with HAs including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuring appropriate follow-up.\n\nParticipate in negotiations with regulatory agencies to resolve and review issues and shepherd proactive interactions with regulators.\n\nEffectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teamsand senior management, as relevant\n\nPrepare and manage GeneFab’sregulatory registrations and/or licenses (e.g., FDA, Oregon Board of Pharmacy).\n\nDevelop and implement a comprehensive quality assurance strategy aligned with the organization's goals and regulatory requirements.\n\nProvide strategic direction and leadership to the Quality Assurance team, fostering a culture of quality excellence and continuous improvement.\n\nCollaborate with cross-functional teams to integrate quality principles into all aspects of the pharmaceutical manufacturing process.\n\nFoster a culture of quality and compliance by promoting awareness and understanding of quality principles throughout the organization.\n\nIndependently provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for projects.\n\nWork in close collaboration with clients, consultants and/or CROs, as needed, to ensure appropriate interactions with HAs.\n\nManage the QA budget to ensure that resources are allocatedappropriately and that all projects are completed on time and within budget.\n\nAll other duties as assigned.\n\nRequirements\nMinimum of a bachelor’s degree, preferably in a scientific discipline.\n\nA minimum of 10 years of experience in compliance, quality, and CDMO/CMO management with a focus on regulatory documentation and lifecycle management.\n\nMinimum of 10 years of GMP/QA experience.\n\nGeneral knowledge of aseptic manufacturing processes.\n\nBroad knowledge of FDA and international regulations related to GMPs and Biopharma.\n\nExperience organizing and managing work responsibilities while working independently with minimal oversight.\n\nTime and project management skills with the ability to multi-task and meet deadlines.\n\nExcellent verbal and written communication skills.\n\nExcellent interpersonal and customer service skills.\n\nExcellent organizational skills and attention to detail.\n\nBroad knowledge of FDA and international regulations related to GMPs and BioPharma.\n\nExperience organizing and managing work responsibilities while working independently with minimal oversight.\n\nKnowledge of GMP requirements and quality regulations within the Biopharma industry, backed by extensive experience in preparing for and successfully navigating inspections conducted by global regulatory agencies, including the FDA and EMA authorities.\n\nExperience with drug substances and drug products is desired.\n\nKnowledge of regulatory requirements across development stages and post-approval is essential.\n\nExpert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.\n\nStrong strategic and analytical abilities, diplomacy, and negotiation skills.\n\nThe ability to collaboratively influences multiple functions and motivates others to accomplish company objectives.\n\nSelf-motivated and detail oriented with sound judgement and innovative thinking to deal with 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