GEM Regulatory Lead - ISEA
Job Type: Full Time
Job Level: Senior
Travel: Minimal (if any)
Location: Singapore, Singapore
About Takeda:
Takeda has been translating science into breakthrough medicines for 240 years. Our teams collaborate to solve challenging problems in drug discovery and development. Today, we are at the forefront of innovative therapies that make a difference to millions of patients worldwide. In our R&D division, we foster diversity of thought and amplify every voice. Join us to advance transformative therapies and shape your bright future.
Objectives/Purpose:
Define, develop, and lead area regulatory strategies in collaboration with line management and Country (LOC) RA Heads.
Maximize regulatory success and enable patient access, including all aspects of submission and timely approval of investigational drugs, marketing authorizations, and life-cycle management submissions.
Communicate regulatory strategies, submission plans, timelines, and impact assessments effectively, including Global Product Team (GPT) representation when relevant.
Liaise with cross-functional stakeholders including Global Regulatory Teams (GRT) to represent GEM RA strategies.
Act as GEM RA Lead for one or more assets for the GEM region from development through life cycle maintenance.
Provide strategic and tactical regulatory advice to global leadership teams.
Lead Submission Working Groups (SWG) for area submissions and represent the area on global and project teams.
Manage or support interactions with Health Authorities in the area in collaboration with stakeholders and LOC RA teams.
Support value and access team in negotiations with Health Authorities when applicable.
Evaluate new business development opportunities and participate in due diligence teams.
Act as Deputy to RA Area Head and support activities for other areas as needed.
Accountabilities:
Demonstrate Takeda leadership behaviors consistently.
Independently manage and work closely with Regional, LOC Regulatory Leads, BU Cross-functional Teams, and Global Regulatory Teams to deliver regulatory activities across the product life cycle.
Oversee and ensure regulatory submissions and approvals are achieved as per schedule.
Communicate effectively with regulators, development teams, and internal leadership.
Provide regulatory expertise on drug development, registration, compliance, and life cycle management.
Participate in authoring/reviewing internal procedures and processes.
Understand and interpret complex scientific issues related to regulatory strategy.
Build effective relationships with LOC Regulatory Leads, Global Regulatory Teams, commercial teams, consultants, and Business Partners.
Actively pursue and oversee the fulfillment of post-marketing commitments.
Present regional regulatory strategies and communicate associated risks, opportunities, and success probabilities.
Dimensions and Aspects:
Technical/Functional (Line) Expertise:
Solid regulatory experience with knowledge across all development phases; understanding of regulations in US, EU, and emerging markets is a plus.
Ability to formulate competitive and accelerated regional regulatory strategies.
Experience with initial MA, indication/line extension applications, lifecycle management, and development submissions.
Experience with advanced therapeutic medical products (Cell & Gene Therapy) is advantageous.
Leadership:
Manage various regulatory development or lifecycle management procedures independently.
Stay updated with regulatory trends and maintain regulatory compliance.
Support individuals holistically and promote an inclusive culture.
Practice active listening and encourage open dialogue.
Act as a trusted, assertive authority among peers.
Decision-making and Autonomy:
Prioritize activities and execute tasks with limited supervision.
Make tactical decisions independently when necessary.
Interaction:
Participate or lead interactions with Health Authorities.
Communicate externally in a concise and respectful manner.
Build strong relationships with Global Teams and LOC RA and other CFTs.
Influence meeting agendas and outcomes effectively.
Complexity:
Function effectively amidst multiple challenges with vitality and confidence.
Develop strategic plans clearly outlining risks and opportunities.
Education, Behavioral Competencies, and Skills:
Bachelor’s degree (BSc.) in a scientific discipline; advanced degree preferred.
Minimum of 8 years of experience in drug regulatory affairs, preferably within the EU/GEM region.
Prior experience within 'area' countries is an advantage.
Fluency in English is required; fluency in local languages is an advantage.
Flexible working hours capability.
Open to feedback and proactive in communication.
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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 :
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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 :
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 :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Najran | Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
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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