Associate Scientific Regulatory Writing Director
Location: Global | Biotechnology & Pharmaceutical Sector
Job Type: Full-Time
Position Overview
The Associate Scientific Regulatory Writing Director leads the development of high-quality regulatory and clinical documents supporting multiple assets across all stages of drug development. This role ensures regulatory submissions are accurate, scientifically rigorous, and compliant with global guidelines. Key document types include clinical and nonclinical summaries (IND/NDA/BLA/MAA), briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports (CSRs), and other complex cross-functional reports.
The ideal candidate combines scientific expertise, regulatory knowledge, and exceptional writing skills to lead content development and guide junior writers, regulatory editors, and cross-functional teams.
Key Responsibilities
Lead content creation for regulatory and clinical documents, including writing, reviewing, editing, and integrating data from multiple sources into coherent, audience-appropriate documents.
Incorporate reviewer feedback while ensuring documents are clear, complete, concise, consistent, and accurate.
Compile and summarize data from statistical tables and other sources into descriptive text and in-text tables.
Assign and oversee tasks of regulatory editors and junior writers, including contract writers as needed.
Manage timelines for document development from initiation through approval.
Oversee assembly of appendices and submission-ready documents.
Serve as the primary writing contact for study/program/project teams.
Provide guidance to internal teams regarding writing standards, regulatory compliance, and organizational goals.
Peer review documents, training materials, and guidelines developed by team members.
Contribute to the development and review of SOPs and work instructions for the Regulatory Science Communications team.
Perform additional duties as required to support regulatory submission excellence.
Supervisory Responsibilities
No direct reports.
Mentors junior writers and regulatory editors.
May direct and review work of contract writers.
Education and Experience Requirements
Education:
BS/BA in a relevant discipline with 11+ years of industry experience, or
MS/MA in a relevant discipline with 9+ years of industry experience, or
PhD in a relevant discipline with 5+ years of industry experience, or
Equivalent combination of education and experience.
Certifications:
Active AMWA membership preferred; AMWA certificate or certification advantageous.
BELS certification is a plus.
Experience:
Proven experience in biotech/pharmaceutical regulatory writing.
Demonstrated leadership in content development for regulatory and clinical documents for submissions (IND/NDA/BLA/MAA, clinical protocols, CSRs, IBs).
Experience with electronic literature tools and scientific/medical abstracts.
Familiarity with oncology therapeutic areas preferred.
Advanced knowledge of drug development processes, regulatory requirements, ICH guidance, and GCP standards.
Expertise in AMA style, medical terminology, and clinical data interpretation.
Skills and Competencies
Strong planning, organizational, and project management skills to meet deadlines and deliver high-quality work.
Excellent verbal and written communication, including clear presentation of complex scientific and regulatory information.
Ability to build productive relationships with internal and external stakeholders.
Proficiency in managing multiple tasks, anticipating challenges, and implementing solutions with broader organizational impact.
Self-motivated, ethical, and committed to professional growth and mentoring.
Collaborative mindset with the ability to guide teams and contribute to organizational goals.
Work Environment
Primarily office-based in a modern, open-plan environment that fosters collaboration and creativity.
Equipped with dual monitors, ergonomic chairs, and necessary tools for high productivity.
Supportive culture encouraging knowledge sharing and professional development.
Compensation and Benefits
Competitive base salary: $148,500 – $209,500 annually, adjusted for geographic location, experience, and internal equity.
Comprehensive benefits package, including:
401(k) with generous company contributions
Medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Employee stock purchase and long-term incentive programs
15 vacation days in the first year, 17 paid holidays including winter shutdown, and up to 10 sick days per year
Disclaimer
This job description outlines the primary responsibilities and qualifications for the role. It is not exhaustive, and additional tasks may be assigned as needed.
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Australia | Richmond Hill | Mississauga | Renfrew | North York | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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