Senior Manager – Regulatory Affairs
Location: Bangalore, Karnataka, India
Company: Apotex Inc.
Employment Type: Full-Time
Role Summary
The Senior Manager – Regulatory Affairs is responsible for leading regulatory activities for co-development and biosimilar products across the United States and Canada markets. This role provides strategic and operational leadership for regulatory submissions, deficiency responses, product lifecycle management (PLCM), and new product launch activities while managing cross-functional teams and external development/manufacturing partners.
The position requires deep expertise in global regulatory affairs, dossier preparation and review, eCTD submissions, regulatory strategy development, health authority interactions, and people leadership to ensure timely approvals and successful commercialization of products.
Key Responsibilities
Regulatory Strategy & Submission Management
Lead regulatory activities for:
Co-development Products
Biosimilar Products
New Product Registrations
Lifecycle Management Initiatives
Develop and execute regulatory strategies for submissions to:
United States Food and Drug Administration (USFDA)
Health Canada
Review and approve:
Regulatory Dossiers
Deficiency Responses
Supplements
Variations
Post-Approval Changes
Ensure regulatory submissions meet quality standards and submission timelines.
Drive regulatory compliance throughout the product lifecycle.
Product Lifecycle Management (PLCM)
Lead Product Lifecycle Management activities for approved products.
Assess and manage:
Label Changes
Manufacturing Changes
Formulation Changes
Process Improvements
Post-Approval Variations
Provide regulatory guidance for proposed changes from third-party manufacturers.
Monitor and track approvals and post-approval commitments.
Co-Development & Biosimilar Project Leadership
Manage co-development projects from development through commercialization.
Coordinate with:
Third-Party Manufacturers
Development Partners
Internal Functional Teams
Ensure alignment between regulatory requirements and project timelines.
Support successful execution of biosimilar development programs.
Drive new product launch readiness activities.
Health Authority Compliance & eCTD Submissions
Ensure high-quality eCTD submissions to regulatory authorities.
Oversee preparation, publishing, and submission of:
New Applications
Deficiency Responses
Supplements
Variations
Annual Reports
Maintain compliance with regulatory submission standards and guidelines.
Monitor submission status and regulatory outcomes.
Cross-Functional Stakeholder Management
Collaborate with:
Research & Development
Quality Assurance
Manufacturing
Supply Chain
Commercial Teams
External Partners
Facilitate effective communication between internal and external stakeholders.
Ensure regulatory alignment throughout product development and commercialization.
Support strategic business decisions through regulatory expertise.
People Leadership & Team Management
Lead, mentor, and develop the Regulatory Affairs team.
Plan and allocate workload based on business priorities and timelines.
Monitor team performance and productivity.
Conduct:
Performance Reviews
Monthly One-on-One Meetings
Coaching & Development Discussions
Build a high-performance culture focused on accountability, collaboration, and continuous improvement.
Ensure appropriate training and competency development for team members.
Operational Excellence & Compliance
Ensure compliance with:
Global Regulatory Requirements
Good Manufacturing Practices (GMP)
Apotex Global Policies
Standard Operating Procedures (SOPs)
Business Ethics & Compliance Programs
Support inspection readiness and regulatory compliance initiatives.
Identify opportunities to improve regulatory processes and operational efficiency.
Drive continuous improvement initiatives within the department.
Environmental Health & Safety (EHS)
Adhere to EHS policies and procedures.
Participate in EHS initiatives and activities as required.
Promote a safe and compliant working environment.
Support organizational health, safety, and environmental objectives.
Required Qualifications
Education
One of the following qualifications:
Master of Science (M.Sc.)
Master of Pharmacy (M.Pharm.)
Doctor of Philosophy (Ph.D.)
Related Scientific Discipline
Experience
15–20 years of experience in Regulatory Affairs within the pharmaceutical industry.
Minimum 3–4 years of experience in:
Team Management
People Leadership
Regulatory Project Leadership
Experience supporting:
USFDA Submissions
Health Canada Submissions
Biosimilar Products
Generic Pharmaceutical Products
Co-development Projects
Experience managing global regulatory submissions and product lifecycle activities.
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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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
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 :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Carlow |Republic of Ireland :
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Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Queensland |Melbourne :
South Yarra |United Kingdom :
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Canada |Quebec :
Montreal |Brussels :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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