{"id":2793807,"url":"https://alion.io/job/parexel-regulatory-strategy-consultant","title":"Regulatory Strategy Consultant","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":83,"open_postings":43,"ghost_share":0,"stale_share":0.884,"repost_share":0,"time_to_fill_p50_days":17,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Biotech","role_family":"Biotech","seniority":"staff","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":101000,"max_usd":208000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":14},"experience_years_min":10,"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":"2026-11-05T22:11:09Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"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(R).\nAbout the Role\nWe are seeking a Regulatory Strategy Consultant to join our team in a remote capacity. As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions. This position plays a key role in advancing clinical development through strategic regulatory planning, lifecycle management, and cross-functional collaboration. You'll work with biopharmaceutical partners to shape regulatory pathways, guide long-range development strategies, and drive submissions that bring new treatments to patients. Responsibilities include leading regulatory strategy development, managing authority engagement, overseeing high-impact submissions, and contributing to long-range development and lifecycle planning.\nYou'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership and advancing clinical research. With diverse teams and continuous learning opportunities, the Regulatory Strategy Consultant can explore career paths and expand expertise across therapeutic areas and development phases.\nKey Responsibilities\nOwn and develop regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirements\nProvide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches\nLead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirements\nDevelop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomes\nCollaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunities\nMonitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches\nCandidate Profile\nYou'll thrive in this role if you bring:\nStrengths in regulatory strategy, strategic planning, and cross-functional leadership\nExtensive experience in clinical development, regulatory affairs, or a highly regulated environment\nThe ability to lead across teams, influence stakeholders, and communicate complex regulatory concepts clearly\nA patient-focused mindset and strong attention to regulatory detail and compliance\nComfort working with regulatory databases, submission management systems, and collaborative platforms\nRequired Qualifications\nBachelor's degree in life sciences, pharmacy, medicine, or related field, or equivalent professional experience\n10+ years of experience in regulatory affairs, clinical development, or related field\nPrevious experience with vaccine and/or biologic products is required\nDeep knowledge of ICH-GCP, FDA and international regulatory requirements, and clinical trial processes\nExperience with regulatory tracking systems, electronic submission tools, and clinical development platforms\nExcellent communication, strategic planning, and problem-solving skills with demonstrated leadership ability\nPreferred Qualifications\nAdvanced degree (M.D., Ph.D., or M.B.A.) or regulatory certification (e.g., RAC) preferred\nExperience in multiple therapeutic areas or development phases\nFamiliarity with global regulatory frameworks and international submission strategies\nFluency in additional languages relevant to regulatory submissions\nBenefits and Compensation\nHealth, Vision & Dental Insurance\nTuition Reimbursement\nVacation/Holiday/Sick Time\nFlexible Spending & Health Savings Accounts\nWork/Life Balance\n401(k) with Company match\nPet Insurance\nFor a complete list of benefits, please visit www.parexel.com/us-benefits.\nSome roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.\nWe offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.\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.\nEEO Disclaimer\nParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.","description_format":"text","description_chars":6280,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Dental insurance","Health insurance","Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-17T21:41:54Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 37 · green card filings: 10","filings_12m":37,"filings_prev_12m":28,"green_card_filings_12m":10,"median_offered_wage_usd":142713,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":34,"band":"fade","label":"Fading","p_open":1,"p_active":0.611,"p_room":0.55,"age_days":20,"expected_fill_days":17,"reasons":["conf:4","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/parexel-regulatory-strategy-consultant","json_url":"https://alion.io/job/parexel-regulatory-strategy-consultant.json","meta":{"generated_at":"2026-11-06T05:43:03Z","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":10074,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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-consultant"},{"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-consultant"},{"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-consultant"},{"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-consultant\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fparexel-regulatory-strategy-consultant"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2793807}},{"tool":"search_jobs","arguments":{"company":"parexel.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2793807},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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