Lead - Regulatory Solutions

10-12 years

Not Disclosed

Bangalore

10 March 10, 2025

Job Description

Job Type: Full Time Education: MBBS/PhD/MDS/BDS/MPharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Lead - Regulatory Solutions

Date: 20 Feb 2025
Location: Bangalore, KA, IN

We are a technology-led healthcare solutions provider, driven by our purpose to enable healthcare organizations to be future-ready. At Indegene, we offer accelerated, global growth opportunities for talent that is bold, industrious, and nimble. We provide a unique career experience that celebrates entrepreneurship, guided by passion, innovation, collaboration, and empathy. Explore exciting opportunities at the convergence of healthcare and technology at www.careers.indegene.com.

Education:

MBBS/PhD/MDS/BDS/MPharm/PharmD

Experience:

10 to 12 years of experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5).

Role Purpose:

Responsible for handling complex Medical Writing projects, reviewing medical writing deliverables supporting the clinical regulatory writing portfolio, and training junior writers.

Skills:

Experience in authoring various clinical documents supporting regulatory filings (Module 2.4, 2.5, 2.6, 2.7, 5.2, CSRs, protocols, amendments, ICFs & IBs).
Expertise in focused/lean writing and editing following defined processes and templates.
Leading cross-functional teams for drafting scientific/medical content addressing data interpretation and product claims.
Understanding of clinical development processes, including clinical trial design.
Strong communication, time management, organizational, and interpersonal skills.
Over two years of people management experience.
Customer-focused with the ability to follow structured processes and templates.
Ability to work independently while maintaining communication with the Sponsor’s MW project manager.
Flexibility to work across Therapeutic Areas as per business needs.
Experience in developing, coordinating, and overseeing work plans for document delivery.
Ability to facilitate review meetings, address feedback, and negotiate solutions.

Knowledge Requirement:

Scientific Knowledge:

Strong understanding of global regulatory guidelines (EU, US, etc.).
Ability to interpret data and apply scientific knowledge for regulatory document writing.
Competency in constructing regulatory arguments using logic, analogy, and therapeutic area science.
Familiarity with medical practices, procedures, medications, and treatments.
Ability to maintain messaging consistency and align with strategic goals.
Experience writing protocols, amendments, CSRs, and CTD summary documents.

Technology Skills:

Expert-level proficiency in MS Word and document management systems.
Experience with eApproval/signature workflows and MS Word add-ins for document management.
Adaptability to new tools and technologies.
Capability to train writers on templates, guidelines, and tools.

Responsibilities:

Prepare/review clinical study reports, protocols, investigator brochures, submission documents (Module 2 summaries), and other regulatory documents for investigational drugs.
Apply lean authoring principles and structured content management text libraries.
Coordinate and initiate activities for document review, quality control, and finalization within tight deadlines.
Develop and maintain project and work plans for team members.
Lead and manage people effectively.
Represent Medical Writing in cross-functional teams.
Conduct document kick-off meetings and ensure standardized content and messaging.
Provide mentorship and coaching for junior team members.
Conduct literature searches and participate in department initiatives.
Stay updated on regulatory landscape and share best practices.
Ensure compliance with company training and reporting policies.

Equal Opportunity Statement:

Indegene is committed to fostering an inclusive and diverse workplace. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. All employment decisions are based on business requirements, candidate merit, and qualifications.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh | Roorkee |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Knoxville | Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | OH | United States |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in England

North Yorkshire :

Harrogate |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & New Zealand & Peru & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Koropi | Athens |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

North Island :

Auckland |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

South Africa | Midrand |

Brazil :

Brazil | Sao paulo |

South America :

Argentina | Peru |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Lead - Regulatory Solutions

Job Description

Education:

Experience:

Role Purpose:

Skills:

Knowledge Requirement:

Scientific Knowledge:

Technology Skills:

Responsibilities:

Equal Opportunity Statement:

Latest Jobs

Senior Cra

Quality Control Lab Technician

Associate Dean Of Clinical Affairs - Hs Associate / Full Clinical Professor

Associate Director, Global Pv Operations - Job Id: Gpv

Representative, Operations

Clinical Data Manager

Global Leader - Mlr Services

Lead - Business Analyst

Associate Manager - Regulatory Solutions

Senior Promotional Copywriter