{"id":4270807,"url":"https://alion.io/job/emd-group-regional-regulatory-affairs-associate","title":"Regional Regulatory Affairs Associate","company":{"id":1844673,"name":"EMD Group","domain":"emdgroup.com","url":"https://alion.io/company/emdgroup","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"A","score":88,"open_postings":40,"ghost_share":0,"stale_share":0.45,"repost_share":0.025,"time_to_fill_p50_days":24,"computed_at":"2026-11-14T05:58:10Z"}},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Taguig, Philippines"],"countries":["PH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-13T17:45:41Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-15T03:30:23Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Work Your Magic with us!\nReady to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.\nYour Role:\nWe are looking for a motivated and detail-oriented APAC RA Regional Hub Associate to join our Regulatory Affairs team. In this role, you will be responsible for executing regulatory submissions across assigned Asian countries, supporting regional and global strategies, and ensuring timely product approvals and compliance. You will work closely with cross-functional teams and contribute to the continuous improvement of our regulatory processes.\nKey Responsibilities\nRegulatory Submissions & Compliance\nExecute all regulatory submissions in assigned Asian countries per regulatory and business requirements.\nEnsure ready-to-submit dossiers are available as per respective country requirements through timely dossier compilation.\nCoordinate labelling compliance and support the promotional material review process.\nTrack regulatory activities for assigned countries and portfolio in relevant company systems.\nReview and assess health authority regulations and competitor intelligence across Asia.\nAs Regional Product Lead (RPL)\nMonitor pipeline and support program/project development.\nCollect data for RA Strategy for new Marketing Authorization Applications (MAA) and Life Cycle Management (LCM).\nProvide support for Early Access Programs (EAP) and Named Patient Sales (NPS).\nEnsure effective communication across RA (top-down and bottom-up) and knowledge sharing about pipeline and portfolio.\nValidate requirements for strategy development and contribute to new project roll-out strategies.\nAct as regional RA representative at cross-functional interactions and meetings.\nOversee dossier availability for LCM and new MAA by collaborating with PPD/REC/GRA/CRA/POC.\nEnsure timely submission and dispatch of dossiers and timely Veeva Vault updates.\nFollow up on approval status of LCM and new MAA in the APAC region and share regular updates with global and regional cross-functional teams.\nEnsure timely AtO preparation, submission, and dispatch for LCM and new MAA.\nSupport the regional TA Coordinator in crisis coordination and management processes.\nAs Country Point of Contact (PoC) / Sub PoC\nManage Early Access Programs (EAP) and Named Patient Sales (NPS) in the country in coordination with the RPL.\nProvide RA strategy input on commercial business cases and country requirements for new projects.\nEngage with country Health Authorities (HA) and ensure timely submission of dossiers for zero-based countries.\nReceive and communicate approval status from HA to RPL and RAA.\nProvide country intelligence to RPL for regulatory assessments and dossier preparation.\nCoordinate with local stakeholders and manage country-specific activities (e.g., Audit, Change Control, Promotional Material Review, Special Permit, Packaging Materials, Tender, HA Inspections, Import License).\nParticipate in HA and industry meetings.\nManage external consultants and business partners, when applicable.\nWho You Are:\nBachelor’s degree in Pharmacy.\nExperience in Regulatory Affairs within the pharmaceutical or healthcare industry, preferably in the APAC region.\nSolid understanding of regulatory submission processes and health authority requirements across Asian markets.\nFamiliarity with dossier preparation, LCM, and MAA processes.\nExperience working with Veeva Vault or similar regulatory document management systems is an advantage.\nStrong project management and organizational skills with the ability to manage multiple priorities.\nExcellent communication and interpersonal skills for cross-functional collaboration.\nAbility to travel as per business needs.\nProficiency in English; additional Asian language skills are a plus.\nWhy Join Us?\nWe are a vibrant science and technology company. We believe in the power of curious minds to create a better world. We offer:\nA collaborative and inclusive work environment that values diversity.\nOpportunities for continuous learning and professional development.\nCompetitive compensation and benefits package.\nThe chance to make a meaningful impact on patients’ lives through innovative healthcare solutions.\nA global network of talented colleagues across more than 65 countries.\nWhat we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!\nApply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!","description_format":"text","description_chars":5223,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Continuous learning","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Advanced Materials","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-11-13T17:45:41Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":24,"reasons":["conf:5","velocity","win:early","comp:brand"],"computed_at":"2026-11-14T05:58:10Z"},"pay":null,"html_url":"https://alion.io/job/emd-group-regional-regulatory-affairs-associate","json_url":"https://alion.io/job/emd-group-regional-regulatory-affairs-associate.json","meta":{"generated_at":"2026-11-15T04:44:36Z","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":419,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-16T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":1844673},"rest":"https://alion.io/mcp/rest/get_company?id=1844673"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Femd-group-regional-regulatory-affairs-associate"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Femd-group-regional-regulatory-affairs-associate"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Femd-group-regional-regulatory-affairs-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/emd-group-regional-regulatory-affairs-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Femd-group-regional-regulatory-affairs-associate"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4270807}},{"tool":"search_jobs","arguments":{"company":"emdgroup.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4270807},"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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