Associate Director, Regulatory Affairs – Oncology
Employment Type: Full Time
Work Model: Hybrid (Remote & On-site)
Job Overview
The Associate Director, Regulatory Affairs – Oncology is responsible for developing and executing global and regional regulatory strategies for assigned oncology assets throughout the product development lifecycle. The role ensures that development programs meet regulatory requirements, support commercial objectives, and achieve optimal product labeling while maintaining compliance with global and regional regulations.
This position works closely with Global Regulatory Leads (GRLs), cross-functional development teams, commercial stakeholders, and health authorities to drive successful regulatory submissions, approvals, and lifecycle management activities.
Key Responsibilities
Regulatory Strategy Development
Develop proactive regional and global regulatory strategies for assigned oncology products.
Ensure regulatory plans align with:
Medicines Development Strategy
Integrated Asset Plans
Target Product Profile
Commercial Objectives
Support development programs across all stages of the product lifecycle.
Assess regulatory risks and develop mitigation strategies.
Regulatory Submission & Approval Management
Lead regional regulatory submissions and approval activities.
Ensure timely preparation and execution of regulatory filings.
Coordinate submission strategies across multiple regions.
Drive successful approval outcomes in accordance with development timelines.
Support post-approval regulatory activities and lifecycle management.
Health Authority Interactions
Lead interactions with regional and local regulatory agencies.
Represent the organization during regulatory meetings and discussions.
Prepare regulatory briefing documents and agency responses.
Manage agency queries and negotiate regulatory requirements when necessary.
Build effective relationships with regulatory authorities.
Cross-Functional Collaboration
Collaborate closely with:
Global Regulatory Teams
Clinical Development Teams
Medical Affairs
Commercial Teams
Safety Teams
CMC Teams
Ensure alignment between global and regional regulatory strategies.
Facilitate matrix team discussions and decision-making.
Oncology Regulatory Leadership
Provide regulatory expertise for:
Solid Tumor Programs
Hematology Programs
Oncology Clinical Development
Support regulatory strategy for innovative oncology products.
Evaluate regulatory implications of clinical and scientific developments.
Regulatory Intelligence & Competitive Analysis
Monitor:
Regulatory precedents
Emerging regulations
Competitor activities
Industry trends
Assess impact of regulatory intelligence on development programs.
Recommend strategic actions based on evolving regulatory landscapes.
Compliance & Governance
Ensure compliance with:
Global Regulatory Requirements
Regional Regulations
Internal Policies and Procedures
Good Clinical Practice (GCP)
Maintain inspection readiness and support audits as required.
Ensure regulatory activities are conducted according to quality standards.
Strategic Leadership
Influence regulatory decision-making across multiple stakeholders.
Support long-term regulatory planning and execution.
Drive continuous improvement in regulatory processes.
Build strong internal networks to facilitate project success.
Qualifications
Education
Bachelor's Degree in:
Pharmacy
Life Sciences
Biotechnology
Medicine
Related Scientific Discipline
Preferred Qualifications
PhD
MD
PharmD
Advanced Scientific Degree
Experience (Minimum Required)
Significant experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
Experience across multiple phases of drug development.
Experience leading:
Regional Development Programs
Regulatory Submissions
Product Approvals
Health Authority Interactions
Preferred Experience
Minimum 2 years of Oncology Regulatory Affairs experience.
Experience in:
Hematology
Solid Tumor Oncology
Experience supporting global development programs.
Experience managing complex regulatory strategies across multiple regions.
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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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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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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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 :
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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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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Australia | Richmond Hill | Uxbridge | North York | Renfrew | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Bangkok |Israel :
Kfar Saba | Be'Er Sheva | Tel Aviv | Yavne | Netanya |Remote :
Riga | Texas | Tulsa | Manipal | Leinster | Castlebar | Zaragoza | Xzagreb | Remote - Africa | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Hungary | Nairobi | Faridabad | Remote - Europe | Slovakia | McFarland | Victoria | Melbourne | Lenexa | Perth | Ireland | Lousiana | Springville | Thailand | Remote - Middle East | Medan | Remote - South America (Latin Americal) | Hammond | Blue Bell | Green Way | Belgium | French | Bishop | Milwaukee | Bountiful | Switzerland |Republic of Colombia :
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King Abdullah Economic City | Rabigh | Jeddah | Riyadh | Khulais | Najran |Kuala Lumpur :
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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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