Job Title: Senior Manager – Regulatory Operations
Location: Princeton, NJ, USA
Department: Regulatory Affairs
Reports To: Senior Manager
Employment Type: Full-Time
Educational Qualification:
Bachelor’s Degree (Life Sciences or related field preferred)
Lead and execute regulatory operations strategies for novel drug development, ensuring compliance with global regulatory requirements, overseeing submissions, and aligning regulatory strategy with business and development objectives.
Regulatory Strategy & Planning:
Develop and execute novel drug regulatory strategies.
Provide high-level review of client programs and develop strategic plans for clinical, analytical, and process development.
Ensure compliance with ICH guidelines and all local country regulatory requirements.
Strategize EU expansion, including MAA planning, submission types (DCP, CP, NP, MRP), country selection, and EU QPPV office setup.
Operations & Project Management:
Manage day-to-day regulatory operations using project management and planning tools; create and maintain detailed project timelines.
Initiate, author, and/or collaborate on SOPs, work instructions, and workflows for regulatory operations, e.g., eCTD submissions, Investigational and Marketing Applications, and post-marketing compliance.
Work closely with development teams to ensure alignment of overall regulatory, CMC, and labeling strategies for pharmaceutical/biological products.
Regulatory Submissions & Liaison:
Author clear and concise regulatory documents (CMC authoring) and oversee all submission documents and messaging.
Serve as the primary point of contact between the company and regulatory agencies, acting as regulatory liaison.
Governance & Compliance:
Maintain awareness of global submission standards, including FDA, HC, EMA, ICH, eCTD, and industry trends for dossier preparation (IND/CTA/NDA/MAA/NDA).
Apply regulatory information management concepts and tools to prioritize operations supporting all business areas.
10–15 years’ experience in regulated life sciences environments.
Strong project management and interpersonal skills.
Experience in defining organizational strategy, process and change management, KPIs and metrics, and resource forecasting.
Extensive knowledge of global submission standards, eCTD publishing systems, TRS toolbox, and regulatory change management.
Knowledge of RoW markets and medical device regulations.
Business development skills.
Sound understanding of regulatory operations tools and concepts.
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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China | Quarry Bay |Hubei :
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Queensland |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Brussels |Flemish Brabant :
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Sofia |Canada :
Canada |Ontario :
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North Ostrobothnia :
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