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Regulatory Affairs Cmc Associate Director

8-10 years
Prefered by Company
10 Nov. 20, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./M.Pharm/B.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

Who We Are
At Teva Pharmaceuticals, our mission is to make good health more affordable and accessible, improving the lives of millions globally. This mission unites our people across nearly 60 countries, bringing together diverse nationalities and backgrounds.

As the world’s leading manufacturer of generic medicines and a producer of many items on the World Health Organization’s Essential Medicines List, we are proud to impact over 200 million lives daily. Yet, we continuously strive for new ways to make a difference, welcoming talented individuals who share our passion for improving healthcare.


The Opportunity
The RA CMC Associate Director provides leadership, strategy, and guidance to regulatory CMC teams supporting Teva’s production site in Kfar Saba, Israel.

This role involves developing and implementing professional standards, streamlining harmonized processes, and managing the daily activities of the RA CMC teams in alignment with site priorities and business strategies.

The global RA CMC team is committed to achieving excellence by fostering collaboration, ensuring compliance, and promoting high performance through Teva’s leadership principles and an enterprise-focused mindset.


How You’ll Spend Your Day

  • Planning & Coordination:

    • Plan and delegate functional activities, ensuring resource availability.
    • Prioritize and coordinate daily tasks of assigned staff and time-critical regulatory activities.
  • Regulatory Expertise:

    • Collaborate with RA CMC, local site teams, and cross-functional teams on project strategies and compliance throughout the product lifecycle.
    • Provide regulatory advice and expertise for submissions and post-approval changes across various markets.
  • Collaboration & Networking:

    • Build networks within and outside the organization to support objectives.
    • Promote cross-team collaboration, leveraging knowledge and skills to advance Teva’s goals.
  • Compliance:

    • Adhere to ICH guidelines, GMP, and internal SOPs while staying updated on industry regulations.
    • Maintain SOPs, participate in the Change Control System, and ensure proper document archiving and database upkeep.
    • Stay informed on pharmaceutical industry developments, legislation, and pharmacopoeia updates to suggest process improvements.
  • Resource & Performance Management:

    • Manage team headcount and recruitment, set goals, provide feedback, and support staff development.
    • Implement company policies, ensure staff training, and maintain accurate job descriptions.
    • Monitor and report on Key Performance Indicators (KPIs).

Your Experience and Qualifications

  • Education:
    • University degree in Science (e.g., Chemistry); advanced degrees (M.Sc., Ph.D.) preferred.
  • Experience:
    • 8–10 years in regulatory affairs or compliance within the pharmaceutical industry.
    • At least 3–5 years in a leadership role.
    • Hands-on experience in RA CMC and drafting CTD sections for registration dossiers.

Why Join Teva?
Beyond meaningful work, Teva offers a holistic benefits package designed to support employees and their families across physical, emotional, and social well-being.

We understand the importance of balancing career and personal life. Our benefits package, among the most comprehensive in Israel, is tailored to support you throughout your life and career.


Reports To:
Senior Director, Regulatory Affairs


For Current Teva Employees
If you are a current Teva employee, please apply through the internal career site on "Employee Central" for priority consideration. The internal career site can also be accessed from your home network. For assistance with your EC account, contact your local HR/IT partner.


Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to creating a diverse and inclusive workplace. We provide equal employment opportunities regardless of age, race, religion, gender, sexual orientation, disability, or any legally protected status.

If you require accommodations during the recruitment process, please let us know. All information provided will remain confidential and will only be used to ensure accessibility for candidates.

Join us in making a difference—together, at Teva.