Regulatory Cmc & Devices Lead

8+ years

Not Disclosed

Hyderabad

10 Dec. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/PhD 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

Job Title: Regulatory CMC and Devices Lead
Location: Hyderabad, India
Job Type: Full-time

About Sanofi

At Sanofi, we are driven by a mission to improve global healthcare by pushing the boundaries of science, innovation, and collaboration. We focus on developing and delivering sustainable health solutions to millions of people worldwide, striving to create a healthier future. Sanofi offers a dynamic and inclusive workplace where people can thrive, grow, and contribute to the transformation of healthcare.

Key Accountabilities

Global Regulatory Strategy: Lead the development of global regulatory CMC (Chemistry, Manufacturing, and Controls) strategies for CHC products in re-development and maintenance phases, including chemical and biological entities, herbals, drugs, and devices.
Sustainability Roadmap Contribution: Contribute to CHC's Clean Ingredients and Sustainability initiatives by ensuring alignment with global CMC strategies.
Regulatory Submissions and Dossiers: Plan and prepare regulatory submissions, including CTAs/INDs, MAAs, international MAs, change amendments, and health authority meetings. Oversee regulatory dossier preparation, review, and publishing processes to ensure timely and high-quality submissions.
Cross-Functional Collaboration: Represent GRA CMC CHC in global cross-functional teams, collaborating with leaders from various departments to drive successful product development and lifecycle management.
Health Authority Engagement: Lead CMC regulatory content for Health Authority meetings and strategic negotiations, ensuring successful and pragmatic outcomes.
Regulatory Intelligence and Risk Management: Contribute to regulatory intelligence efforts and keep up to date with local and global CMC regulations. Identify and mitigate risks associated with CMC activities.
CMC Training and Mentorship: Mentor and guide junior staff and team members, sharing knowledge and expertise in regulatory CMC processes and strategy development.

Skills, Experience & Knowledge Requirements

Education: Master’s degree in a science/health field (e.g., Pharmacy, Analytical Chemistry, Biological/Biotechnology Sciences) or equivalent; Advanced degree (Master, PhD) preferred.
Experience:
- Minimum of 8 years of relevant experience in regulatory CMC.
- Global regulatory CMC experience is required; additional experience in pharmaceutical CMC (laboratory, development, manufacturing) is preferred.
- Demonstrated experience in developing regulatory CMC strategies for medicinal products.
- Knowledge of CMC requirements for probiotics, food supplements, and medical devices is an advantage.
- Experience with regulatory health authorities is a plus.
Technical Skills:
- In-depth knowledge of global CMC regulations and guidelines.
- Proficiency in using digital tools like Veeva Vault RIM, MS Word, Excel, PowerPoint, SharePoint.
Personal Characteristics:
- Strong strategic thinking and ability to work independently.
- Excellent interpersonal and communication skills, both oral and written.
- Strong team player with the ability to work in a matrix structure.
- Self-motivated, entrepreneurial, and solutions-oriented with a "can-do" attitude.
- “Think outside the box” mindset.

Why Sanofi?

At Sanofi, we offer a culture that encourages growth, collaboration, and innovation. As a part of our team, you will contribute to impactful work, surrounded by a diverse and inclusive group of professionals. We are committed to providing equal opportunities to all individuals and supporting their development in an environment where everyone can thrive.

Equal Opportunity Employer

Sanofi is committed to diversity and inclusion. We provide equal opportunities to all individuals regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Pursue progress. Discover extraordinary.
Join Sanofi in shaping the future of healthcare and be part of a global team working toward meaningful change.

Latest Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

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 :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

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 |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

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 |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

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 |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

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

Ontario :

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) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

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 :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Regulatory Cmc & Devices Lead

Job Description

About Sanofi

Key Accountabilities

Skills, Experience & Knowledge Requirements

Why Sanofi?

Equal Opportunity Employer

Latest Jobs

Medical Review Officer

Senior Medical Safety Analyst - Nutrition - Columbus

Associate Clinical Site Lead

Clinical Site Lead - Los Angeles

Medical Director, Crm Medical Affairs

Patient Therapy Access Specialist