Manager Regulatory Affairs CMC - Innovative Medicines

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

How you’ll spend your day

• Develop, coordinate, and support the CMC aspects of regulatory submissions to global Health Authorities for innovative medicines.
• Lead and implement regional and/or global CMC strategy and submission activities, including:
  • Planning, writing, reviewing, coordinating, and submitting CMC sections of regulatory filings for assigned projects and products.
• Arrange, coordinate, and lead the team in planning, preparation, and execution of meetings or teleconferences with Health Authorities (e.g., FDA, EMA) as lead facilitator.
• Guide subject matter experts (SMEs), Operations, and/or QA functions to implement activities aligned with global strategies and regulatory agency requests and guidance.
• Anticipate and understand the needs of internal and external customers.
• Identify current key issues and anticipate future ones, taking them into consideration when planning and managing projects.
• Challenge the status quo to achieve continuous improvement.
• Manage change control: coordinate and assess regional/global change records.

Your experience and qualifications

Education:

• Required: Bachelor’s degree in a scientific field (Pharmacy, Chemistry, Biochemistry, Biotechnology, or equivalent)
• Preferred: Master’s degree, PhD, or PharmD

Experience:

• Required: Minimum 4 years of pharmaceutical industry experience, preferably in regulatory affairs
• Preferred: Minimum 6 years of regulatory affairs experience with proven success in filing and defending major submissions

Technical competencies:

• Strong background in pharmaceutical development with focus on CMC (drug substance and drug product)
• Experience with ICH Guidelines Q8, Q9, Q10 and ObD principles
• Familiarity with CTD filings (Modules 2 and 3), content, and regional CMC requirements
• Working knowledge of relevant drug and biologic laws, regulations, and guidelines
• Knowledge of pharmaceutical drug development process
• Proficient in project management

Soft skills and behavioral competencies:

• Ability to manage multiple projects and competing timelines
• Strong strategic and scientific thinking
• Good interpersonal, communication, organizational, and negotiation skills
• Ability to influence through logical, reasoned communication and respond constructively to others’ needs

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.