Director, Vaccine Mature Products, Cmc

10+ years

Not Disclosed

Italy North Carolina

10 Jan. 21, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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: Director, Vaccine Mature Products, CMC

Location Options:

Siena, Italy
Wavre, Belgium
London, United Kingdom
Durham, North Carolina, USA

Category: Regulatory
Posted Date: January 7, 2025
Closing Date for Applications: January 21, 2025 (COB)

Company Overview:

GSK is a global biopharmaceutical company with a mission to unite science, technology, and talent to get ahead of disease together. We focus on four core therapeutic areas:

Infectious Diseases
HIV
Respiratory/Immunology
Oncology

We are committed to positively impacting the health of 2.5 billion people over the next 10 years, utilizing cutting-edge science and technology to transform medical discovery. Our approach integrates strong tech-enabled capabilities, building a deeper understanding of human biology, disease mechanisms, and patient needs.

Role Overview:

The Director, Vaccine Mature Products, CMC will lead and oversee strategic CMC regulatory activities during the late development and global lifecycle management of GSK vaccine products. This includes providing guidance across cross-functional teams and ensuring compliance with GSK policies and external regulatory requirements.

This role requires leadership in managing the lifecycle of vaccines, driving regulatory strategy, and influencing internal/external stakeholders to maintain high-quality standards.

Key Responsibilities:

Global CMC Leadership:
Represent Global CMC Regulatory on regulatory networks and matrix teams, overseeing strategic direction and providing guidance on key business initiatives, including interactions with Supply Chain, Quality Assurance, 3rd Party Contract Management, and other internal departments.
Risk Identification & Mitigation:
Identify risks associated with submission strategy and information packages, advising senior management on risk mitigation strategies.
Line Management & Staff Development:
Likely to have direct line management responsibilities. Mentor and coach staff within the CMC Regulatory team, ensuring continuous development and training.
Budget & Resource Management:
Oversee the budget and resources allocated to the team, ensuring efficient use and compliance with GSK policies and procedures.
Regulatory Strategy for Inspections & Quality Incidents:
Lead the CMC regulatory strategy during major inspections (e.g., PAI’s) or quality incidents (e.g., LICs/PIRCs), providing expert advice.
Internal/External Influence:
Lead key initiatives on behalf of the company, influencing both internal and external regulatory environments through specialized knowledge and intelligence.
Submission Management:
Ensure successful submission of global CMC applications, advising on regulations, guidelines, and strategies to expedite review and approval in alignment with regional requirements.
Lifecycle Management Support:
Lead license maintenance activities, supporting change control requests and managing transfer of supply within GSK or with third-party suppliers.
Process Improvement:
Formulate and implement novel approaches to improve CMC regulatory processes, enhancing the efficiency and quality of departmental work.
Leadership & Communication:
Operate independently to handle complex regulatory issues, influencing senior leadership and external agencies on CMC projects and policy matters.

Basic Qualifications:

We are looking for professionals with the following skills and qualifications to succeed in this role:

Knowledge & Experience:
- Detailed understanding of drug development, manufacturing, and global CMC regulatory requirements.
- Proven ability to influence the regulatory environment both internally and externally.
Project Management Skills:
- Strong multi-tasking and project management abilities, handling complex global CMC issues and adapting to continuous change.
Regulatory Expertise:
- Experience in major post-approval filings, including significant manufacturing changes and key regulatory interactions.
Influence & Negotiation:
- Track record of influencing and negotiating with regulatory agencies, industry bodies, and internal teams to ensure successful outcomes.
Leadership Abilities:
- Experience in leading teams, developing talent, and ensuring compliance with industry standards.

Preferred Qualifications:

The following qualifications are not mandatory but would be beneficial:

Life Cycle Management Experience:
- Experience in lifecycle management, ideally within pharmaceutical and vaccine product support.
Professional Development:
- Experience in identifying new opportunities for educating colleagues and developing strategies to meet evolving regulatory requirements.
Specialist Expertise:
- Recognized as an expert in CMC Regulatory within a specific subject area.
Team Leadership:
- Proven experience in supervising and training staff across departments and teams.

Why GSK?

At GSK, we offer:

Competitive Salary and Annual Bonus based on company performance
Healthcare & Wellbeing Programs
Pension Plan and Shares & Savings Program
Hybrid Working model, providing flexibility between remote and in-office work
Career Development opportunities in a collaborative environment

We are committed to making GSK a place where people feel welcome, valued, and included, with a focus on growth, safety, and well-being.

Application Instructions:

To apply for this role, please submit a cover letter and CV outlining how your skills and experiences align with the job requirements. This information will be used to assess your suitability for the role.

Equal Opportunity Employer:

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected .

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