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במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
We Are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
Our Team, Your Impact
This role serves as a Regulatory Affairs Subject Matter Expert (SME) supporting RA evaluations, regulatory planning, and risk assessments for the International Markets (IM) portfolio. The position provides expert input to estimate regulatory requirements, supporting data needs, and associated risks across diverse international markets, with a focus on site transfers, CMC changes, and network strategy initiatives.
The role works closely with sending and receiving sites, MS&T, Quality, ExM, and RA teams to ensure accurate regulatory impact assessments and effective mitigation strategies aligned with IM regulatory standards and requirements.
This position has an essential role to ensure coordinated, consistent, and timely RA execution aligned with the overall TGO Network Strategy.
How You’ll Spend Your Day
RA Evaluations & Planning (IM Focus)
- Provide SME input to RA evaluations and regulatory planning activities for the IM portfolio.
- Assess and coordinate regulatory requirements, submission strategies, and approval risks across multiple international markets.
- Support early‑phase planning by identifying market‑specific regulatory requirements related dependencies, and timelines.
- Evaluate regulatory risks associated with site transfers, CMC changes, and network initiatives impacting IM markets.
- Contribute to complexity assessments and gap analyses, with a focus on IM regulatory requirements.
- Propose pragmatic risk mitigation strategies and supporting document/evidence aligned with local HA requirements.
- Work closely with sending and receiving manufacturing sites, MS&T, ExM, Quality, and submission teams.
- Provide regulatory guidance on supporting data requirements (CMC, comparability, stability, validation, etc.).
- Ensure alignment between technical transfer plans and IM regulatory strategies.
- Act as an IM RA SME, providing insight into regional regulatory pathways, documentation expectations, and approval risks.
- Support RA teams with interpretation of IM‑specific regulations, guidelines, and precedents.
- Enable consistent, risk-informed and realistic regulatory planning across IM markets.
- Share IM regulatory knowledge, lessons learned, and best practices with project and RA teams.
- Enable standardized and consistent approaches, assumptions, and planning principles for IM regulatory evaluations.
- Bachelor’s or advanced degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, or related field).
- Extensive experience in Regulatory Affairs (at least 10 years) with at least 3 years experience with International Markets.
- Hands‑on experience supporting site transfers, CMC changes, or network initiatives impacting IM markets.
- Strong understanding of global and regional regulatory requirements and HA expectations.
- Strong understanding of IM regulatory variability and its impact on data requirements and timelines.
- Ability to translate complex regulatory data into clear strategic direction.
- Works effectively and collaboratively across functions, geographies, and cultures.
- Comfortable operating in a dynamic environment with evolving project scope and regulatory challenges.
- Able to balance strategic thinking with hands‑on SME contribution.
- Excellent communication, analytical, and organizational skills.
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
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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.
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
שאלות ותשובות עבור משרת Project Manager Optimization Network
מנהל פרויקטים לאופטימיזציה רשתית ב-Teva Pharmaceuticals משמש כמומחה לנושאי רגולציה (SME) ותומך בהערכות רגולטוריות, תכנון רגולטורי והערכות סיכונים עבור תיק השווקים הבינלאומיים (IM). התפקיד מתמקד במתן קלט מומחה להערכת דרישות רגולטוריות, צרכי נתונים תומכים וסיכונים קשורים במגוון שווקים בינלאומיים, עם דגש על העברות אתרים, שינויי CMC ויוזמות אסטרטגיית רשת.
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