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    Manager/Senior Manager - Regulatory Affairs - Innovative Medicines, Europe

    Teva Pharmaceuticals
    3-5 years
    Prefered by Company
    Harlow
    10 Nov. 20, 2024
    Job Description
    Job Type: Full Time Education: B.sc./M.Sc./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

    Who We Are

    At Teva Pharmaceuticals, we are committed to making good health more affordable and accessible to millions worldwide. With a presence in nearly 60 countries, we bring together diverse nationalities and backgrounds.

    As the world’s leading manufacturer of innovative and generic medicines and a producer of many products on the World Health Organization’s Essential Medicines List, we impact at least 200 million lives every day. While this is a significant achievement, we continue to seek new ways to make a difference and welcome individuals ready to join our mission.

    The Opportunity

    We are hiring a Manager or Senior Manager - Regulatory Affairs to join the Global Regulatory Affairs – Innovative Medicines (Europe) team. In this role, you will work on key innovative products that are part of Teva’s Pivot to Growth strategy.

    Our Harlow office, Teva’s Centre of Excellence (CoE) for Regulatory Affairs, specializes in European and global licensing for medicines and OTC products. Conveniently located just 30 minutes from central London, we offer a hybrid work environment.

    Key Responsibilities

    Regulatory Strategy & Approvals

    • Develop regulatory strategies for submissions to EU Competent Authorities during the development, approval, and post-approval phases.
    • Obtain regulatory approvals and feedback/decisions from European Competent Authorities for innovative medicinal products.
    • Provide regulatory guidance to cross-functional teams within Teva.

    Clinical Trials & Product Registration

    • Support Clinical Trial Applications (CTAs) under the new Clinical Trials Regulation.
    • Obtain and maintain registrations for innovative medicinal products in the EU.

    Global Responsibilities (if applicable)

    • Act as a Global Regulatory Lead, depending on experience, to oversee regulatory strategies and submissions on a global scale.

    Your Experience and Qualifications

    Education:

    • BSc in Life or Pharmaceutical/Healthcare Sciences (required).
    • MSc or PhD in a relevant field (preferred).

    Experience:

    • Substantial European regulatory affairs experience (required).
    • Experience with CTAs in the EU (required).
    • Experience with innovative medicines in therapeutic areas such as Immunology, Oncology, Gastroenterology, or Respiratory (preferred).
    • Knowledge of Medical Devices and the Medical Device Regulation (advantageous).

    Skills & Competencies:

    • Leadership: Strong leadership and interpersonal skills.
    • Communication: Excellent verbal and written communication skills, with confidence in presenting to local and global groups.
    • Strategic Thinking: Ability to develop strategic approaches and solve complex problems.
    • Time Management: Capable of working under pressure to meet tight deadlines.

    Enjoy a More Rewarding Choice

    Work-Life Balance:

    • 25 days of annual leave.
    • Hybrid working approach.
    • Car or car allowance.

    Health & Wellness:

    • Private health insurance for you and your family.
    • Life & Critical Illness Insurance.
    • Sports and Health Programme, including health days and nutritional counseling.

    Recognition & Growth:

    • Recognition programs and company bonus scheme.
    • Access to Teva’s Virtual Learning Centre.

    Inclusive Workplace:

    • Well-being and Diversity & Inclusion (D&I)-focused initiatives.

    Role Details

    • Function: Regulatory Affairs.
    • Sub-Function: Medical Regulatory Affairs.
    • Reports To: Associate Director, EU Regulatory Affairs Innovative Medicines.

    Already Working @Teva?

    If you’re a current Teva employee, apply through the internal career site on "Employee Central" to receive priority consideration. You’ll also find opportunities exclusively open to Teva employees.

    For EC access assistance, contact your local HR/IT partner.

    Teva’s Equal Employment Opportunity Commitment

    Teva Pharmaceuticals is an equal opportunity employer. We ensure equal employment opportunities are provided without regard to age, race, creed, religion, gender, sexual orientation, disability, or other protected statuses.

    We are committed to fostering a diverse and inclusive workplace. If you require accommodations during the recruitment process, please let us know. All information will remain confidential and used solely to support an accessible candidate experience.

    Make a difference with Teva Pharmaceuticals.

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