Regulatory Operations Senior Manager
Location: [Not specified]
Experience Required: 10–15 years in regulatory/life sciences
Job Type: Full-Time
Job Description:
We are currently seeking a Senior Manager – Regulatory Operations to join our growing team. This leadership role is critical for driving regulatory strategies, leading submissions across global markets, and ensuring compliance with evolving regulatory frameworks including FDA, EMA, and RoW.
Key Responsibilities:
Strategic Regulatory Oversight:
Develop and implement novel drug regulatory strategies across various markets.
Lead and manage daily operations using project management tools and detailed project timelines.
Provide high-level regulatory advice on development, compliance, and submission planning.
Support expansion strategy for EU MAA submissions (DCP, CP, NP, MRP), including RMS/CMS country selection and setup of EU QPPV office.
Regulatory Documentation & Compliance:
Author and review clear, concise regulatory documentation including CMC sections.
Oversee global eCTD submission processes: Investigational (IND/CTA), Marketing (NDA/MAA), and post-marketing compliance.
Ensure all programs adhere to ICH, FDA, EMA, and country-specific regulations.
Cross-Functional Collaboration:
Collaborate closely with cross-functional teams (clinical, analytical, CMC, labeling) to align regulatory, development, and operational strategy.
Act as Regulatory Liaison with global Health Authorities.
Drive internal process optimization by initiating SOPs, workflows, and quality systems within Regulatory Operations.
Desirable Skills and Experience:
10–15 years’ experience in a regulated life sciences environment (pharmaceutical/biotech/medical device).
Strong project and change management capabilities.
In-depth knowledge of FDA, EMA, HC, ICH, eCTD, and international regulatory requirements.
Familiarity with TRS Toolbox, RIM systems, and eCTD publishing tools.
Experience in business development, organizational strategy, and metrics/KPIs.
Exposure to Rest of World (RoW) markets and medical device regulations is a plus.
Excellent interpersonal, communication, and stakeholder management skills.
Estimated Salary: ₹35 LPA – ₹55 LPA (depending on experience and skillset)
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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 :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
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Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Australia | Mississauga | North York | Uxbridge | Richmond Hill | Renfrew |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
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Surabaya |Jakarta :
Jakarta |Israel :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
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King Abdullah Economic City | Riyadh | Jeddah | Rabigh | Khulais | Najran |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
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Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |