{"id":2793806,"url":"https://alion.io/job/parexel-regulatory-strategy-senior-associate","title":"Regulatory Strategy Senior Associate","company":{"id":2735,"name":"Parexel","domain":"parexel.com","url":"https://alion.io/company/parexel","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":41,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":11,"computed_at":"2026-10-23T05:54:15Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Canada"],"countries":["CA"],"hiring_countries":["CA"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":111000,"period":"year","method":"role_seniority_country_cell","sample_n":58},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-16T00:00:00Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-22T02:53:23Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"When our values align, there's no limit to what we can achieve.\nAt Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.\nEach of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.\nAbout Parexel\nParexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.\nWe work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.\nAbout the Role\nWe are seeking a Regulatory Strategy Senior Associate to join our team in a remote capacity. As a Regulatory Strategy Senior Associate, you will support regulatory strategy initiatives that advance new treatments for patients. This position plays a key role in regulatory pathway planning, agency engagement support, and strategic compliance oversight. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy from planning through implementation. Responsibilities include developing regulatory pathway recommendations, supporting agency engagement planning, and identifying key risks and opportunities, with opportunities to deepen your expertise and influence regulatory outcomes.\nYou'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory guidance and product development support. With diverse teams and continuous learning opportunities, the Regulatory Strategy Senior Associate can explore career paths and expand skills across regulatory affairs and clinical development.\nKey Responsibilities\nDevelop and recommend regulatory pathways for assigned products, studies, or markets\nSupport agency engagement planning and prepare materials for regulatory meetings\nIdentify key regulatory risks and opportunities to inform development strategy\nAlign regulatory approaches with development and commercialization objectives\nMaintain current knowledge of regulatory requirements and industry guidance\nCollaborate with cross-functional teams to ensure regulatory compliance and strategic alignment\nPrepare regulatory documentation and submissions as needed\nTrack regulatory timelines and milestones to support program execution\nCandidate Profile\nYou'll thrive in this role if you bring:\nStrengths in regulatory strategy, strategic thinking, and problem-solving\nExperience working in regulatory affairs, clinical development, or a regulated environment\nThe ability to collaborate across teams and communicate clearly with internal and external stakeholders\nA patient-focused mindset and strong attention to detail\nComfort working with regulatory databases, submission tracking systems, and standard office tools\nRequired Qualifications\nBachelor's degree in life sciences, regulatory affairs, pharmacy, or related field, or equivalent professional experience\n4+ years of experience in regulatory affairs, clinical development, or a related field\nPrevious experience with vaccine and/or biologic products is required\nFDA regulation expertise/knowledge is required and experience with other global markets is preferred\nKnowledge of ICH-GCP, regulatory requirements, and clinical trial processes\nExperience with regulatory databases or submission tracking systems\nStrong communication, organization, and problem-solving skills\nPreferred Qualifications\nAdvanced degree in regulatory affairs, pharmacy, or related field\nExperience in specific therapeutic areas or development phases\nFamiliarity with regulatory submission software or electronic tracking systems\nExperience supporting FDA or international regulatory submissions\nIf this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!\nWe believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.\n#LI-LB1","description_format":"text","description_chars":4816,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning"],"hiring_locations":[{"name":"Canada","iso":"CA","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-17T21:41:54Z"}],"visa":[],"liveness":{"score":50,"band":"ok","label":"Likely open","p_open":1,"p_active":0.559,"p_room":0.9,"age_days":7,"expected_fill_days":11,"reasons":["conf:27","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/parexel-regulatory-strategy-senior-associate","json_url":"https://alion.io/job/parexel-regulatory-strategy-senior-associate.json","meta":{"generated_at":"2026-10-24T01:35:40Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":2617,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2735},"rest":"https://alion.io/mcp/rest/get_company?id=2735"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fparexel-regulatory-strategy-senior-associate"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fparexel-regulatory-strategy-senior-associate"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fparexel-regulatory-strategy-senior-associate"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/parexel-regulatory-strategy-senior-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fparexel-regulatory-strategy-senior-associate"}]}