Associate Director, Global Regulatory Affairs Labeling Compliance

8+ years

Not Disclosed

Remote Zurich

10 Nov. 27, 2024

Job Description

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

Regulatory Affairs - Labeling, Associate Director

Location: [Not specified in the provided description]

About the Role

The Regulatory Affairs - Labeling, Associate Director ensures Takeda maintains compliance with global and local labeling requirements while supporting product approvals, amendments, and lifecycle management. The role contributes to strategic and operational labeling compliance activities, collaborating across functions and managing systems and processes to align with regulatory requirements.

How You Will Contribute

Leadership & Collaboration:

Partner with global teams to communicate and align on labeling compliance strategies and metrics.
Collaborate with internal and external stakeholders to ensure consistent labeling processes.

Process Development & Oversight:

Lead the development and implementation of global and local labeling compliance processes, including systems for tracking labeling events and updates.
Monitor and ensure alignment with external guidelines and regulatory requirements, including oversight of regulatory documentation (e.g., PSMF Annex F tables).

Audit and Inspection Readiness:

Ensure the organization is prepared for internal and external audits and inspections.
Lead the collection, review, and submission of labeling documentation during inspections.
Present labeling processes to auditors and develop responses and CAPAs.

Risk Management & Reporting:

Identify and mitigate risks of non-compliance, escalating issues to senior leadership as needed.
Maintain a repository for tracking labeling commitments to third parties and partners.

Strategic Initiatives:

Drive initiatives to enhance labeling compliance and integrate best practices.
Represent Takeda in industry forums to stay abreast of regulatory and labeling trends.

Qualifications

Education & Experience:

Bachelor’s degree required; Master’s degree preferred.
8+ years in the pharmaceutical industry with experience in regulatory affairs, labeling, quality assurance, and compliance.
Familiarity with global health authority regulations and labeling lifecycle management.
Experience working in a global, cross-functional, and multicultural environment.

Skills & Competencies:

Regulatory Knowledge: Strong understanding of global and local labeling requirements, including 21 CFR, European, and international regulations.
System Expertise: Proficient in Quality Management Systems (eDMS, Trackwise) and regulatory compliance systems.
Analytical Skills: Strong problem-solving abilities with experience in TQM or Six Sigma methodologies.
Communication & Leadership: Proven ability to lead teams, manage priorities, and articulate complex regulatory concepts clearly.
Project Management: Effective at managing projects and cross-regional teams in a matrixed organization.

Behavioral Competencies:

Adaptability to manage interpersonal dynamics effectively.
Team player with a collaborative mindset and ability to motivate and empower others.
Knowledge sharing to enhance organizational processes and deliverables.

What You Bring to Takeda

A strategic approach to labeling compliance with operational expertise.
Ability to drive collaboration and foster innovation across teams.
Commitment to maintaining high-quality standards and ensuring inspection readiness.

Why Takeda?

At Takeda, we are dedicated to bringing better health to people and building a brighter future through innovative therapies. This role offers a unique opportunity to lead impactful compliance initiatives while working in a collaborative, diverse environment.

#LI-Hybrid

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji |

Gujarat :

Haryana :

Himachal Pradesh :

Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

PAN-India :

Panjab :

Punjab :

Rajasthan :

Banasthali | Jaipur | Pilani | Udaipur |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

Bridgeport | Enfield | Groton | Storrs |

D.C :

Washington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Lawrence |

Kenlucky :

Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maryland :

Baltimore | Elkridge | Gaithersburg | Rockville |

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Minneapolis and St. Paul, Minnesota. | St.Paul |

Missouri :

Fulton | St. Louis |

Nevada :

Las Vegas |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Santa Fe |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

Ohio :

Cincinnati | Cleveland | Columbus, | Macedonia |

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Nashville |

Texas :

United states :

Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

Bothell | Goldendale | Pullman | Seattle |

WI :

Madison | Wausau |

Wisconsin :

Wyoming :

Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Marburg |

Hessen :

Frankfurt |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Latvia | Leuven | Poland | Spain |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

Hubei :

Wuhan |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Argentina & Australia & Austria & Belgium & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Finland & France & Greece & Indonesia & Ireland & Israel & Italy & Japan & Kazakhstan & Korea & Netherland & Philippines & Poland & Portugal & Remote & Saudi Arabia & Singapore & South Afrcia & South America & Spain & Taiwan & Tennessee & Thailand & Turkey & United Arab Emirates

Buenos Aires :

Buenos Aires |

New South Wales :

Sydney |

Queensland :

Queensland |

Republic of Western Australia :

Nedlands |

Austria :

Austria |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Canada :

Canada |

Ontario :

Richmond Hill | North York | Uxbridge |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

United Kingdom :

Estonia :

Estonia |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Paris | Lyon |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Cork :

Ringaskiddy |

County Dublin :

Swords |

Republic of Ireland :

Limerick | Waterford | Dublin |

Israel :

Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |

Italy :

Italy |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Republic of Korea :

Seoul |

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Remote - Europe | Remote | Switzerland | Remote, USA |

Makkah :

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Dubai :

Dubai |

Associate Director, Global Regulatory Affairs Labeling Compliance

Job Description

Regulatory Affairs - Labeling, Associate Director

About the Role

How You Will Contribute

Leadership & Collaboration:

Process Development & Oversight:

Audit and Inspection Readiness:

Risk Management & Reporting:

Strategic Initiatives:

Qualifications

Education & Experience:

Skills & Competencies:

Behavioral Competencies:

What You Bring to Takeda

Why Takeda?

Latest Jobs

Global Medical Communications Lead, Dermatology

Head Of Medical Affairs, Gem

Medical Science Liaison- Hematology- Houston, Tx And Louisiana

Msl Manager, Medical, Beijing

Medical/Scientific Liaison (Msl)

Director, Translational Medicine Neurology

Director, Medical Safety Assessment Physician

(Sr.) Msl, Medical, Hangzhou

Global Head, Field Medical Excellence (Fme)

Medical Science Liason Pl.

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in China