Manager – Regulatory Operations
Company: Piramal Critical Care
Location: Mumbai (Kurla)
Department: Regulatory Affairs – Regulatory Operations
Employment Type: Full-Time
Experience Required: 5–10+ Years
Travel Requirement: Low Travel
Reporting To: Associate Director – Regulatory Operations
Job Summary
Piramal Critical Care is seeking an experienced Manager – Regulatory Operations to lead global regulatory publishing and submission activities across the United States, Europe, and other international markets. The role involves managing a team of publishing professionals, overseeing electronic submissions, ensuring compliance with global regulatory requirements, and driving continuous improvement initiatives within Regulatory Operations.
The successful candidate will possess strong expertise in eCTD publishing, regulatory systems, submission management, and people leadership while supporting global regulatory strategies and operational excellence.
Key Responsibilities
Regulatory Publishing Leadership
Lead and manage a team of Regulatory Publishing Specialists and Publishing Experts.
Plan, assign, review, and oversee publishing activities for multiple products and projects.
Ensure timely preparation, review, and submission of regulatory dossiers.
Drive operational excellence and support the long-term vision of Regulatory Operations.
Electronic Submission Management
Publish and review electronic regulatory submissions in eCTD format.
Manage new registrations, lifecycle management submissions, variations, supplements, and renewals.
Submit applications through:
Electronic Submission Gateway (ESG)
Common European Submission Portal (CESP)
Other global submission platforms
Support veterinary product submissions for US and EU markets.
Global Regulatory Compliance
Ensure all submissions comply with:
US FDA requirements
European Medicines Agency (EMA) requirements
TGA requirements
Health Canada requirements
Other global regulatory authority requirements
Monitor evolving regulatory submission standards and communicate updates to stakeholders.
Ensure publishing software and submission tools remain compliant with current eCTD versions.
Regulatory Systems Management
Provide expertise and guidance on:
Lorenz DocuBridge
Regulatory Information Management Systems (RIMS)
Electronic Document Management Systems (EDMS)
eCTD publishing platforms
Support implementation, upgrades, validation, and optimization of regulatory systems.
Develop User Requirement Specifications (URS) and Requests for Proposal (RFPs) for new systems.
Quality Control & Technical Review
Conduct quality reviews of submission packages.
Verify document integrity, hyperlinking, bookmarking, lifecycle management, and metadata compliance.
Troubleshoot publishing and submission issues.
Ensure high-quality submission standards across all regulatory filings.
Aggregate Safety Reporting Support
Manage compilation and submission of:
Periodic Adverse Drug Experience Reports (PADERs)
Periodic Safety Update Reports (PSURs)
Other regulatory safety reports
Coordinate with Pharmacovigilance and Medical Affairs teams for regulatory compliance.
Process Improvement & Digital Transformation
Drive automation initiatives for submission tracking and regulatory workflows.
Participate in business transformation and operational excellence projects.
Recommend improvements to publishing processes and regulatory systems.
Support implementation of innovative technologies and digital solutions.
Metrics & Reporting
Develop and maintain regulatory operations metrics.
Monitor publishing performance and submission timelines.
Present operational updates and compliance reports to leadership teams.
Cross-Functional Collaboration
Collaborate closely with:
Regulatory Affairs Teams
Pharmacovigilance
Medical Affairs
Program Management
Quality Assurance
Global Regulatory Stakeholders
Participate in agency meetings, teleconferences, and industry forums.
Required Qualifications
Education
B.Pharm, M.Pharm, Life Sciences, or related scientific discipline.
Experience
5–10+ years of Regulatory Operations and Regulatory Publishing experience.
Strong experience supporting:
US FDA submissions
European Union submissions
eCTD publishing activities
Experience in Canada, Australia, and Rest-of-World submissions is preferred.
Prior people management experience is highly desirable.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
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Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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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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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
Richmond Hill | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Buenos Aires |Republic of Egypt :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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