Sr Mgr Regulatory Affairs

Who We Are
Teva Pharmaceuticals is a global biopharmaceutical company that has a century-long history of growing and evolving as a business. Today, Teva is at a critical juncture of transformation, building on its foundational business and operational excellence and assembling a portfolio of novel innovative medicines and biopharmaceutical products, following the announcement of our new corporate strategic framework, Pivot to Growth, with four main pillars to position the company for a new era of growth.
Teva is the worlds largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients, and we have built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
The opportunity

• Teva’s Global Regulatory Affairs Policy and Intelligence (GRAPI) team is at the forefront of regulatory policy and intelligence, transforming complex regulatory landscape updates into actionable insights to inform regulatory strategy and cross-functional strategic decision-making. This role will support GRAPI team in positioning as the definitive source of regulatory intelligence empowering Teva cross-functional teams to navigate regulatory complexity with confidence and foresight.
• We are seeking an exceptional expert in Global Regulatory Intelligence to help drive innovation in regulatory intelligence practices. This pivotal role will be responsible for orchestrating a world-class regulatory intelligence practice that anticipates, interprets, and contextualizes regulatory changes globally across key markets, develops global policy positions on key topics with cross-functional input, and services internal regulatory intelligence queries. The role will also provide regulatory policy support for key international markets in collaboration with International Markets (IM) Regulatory Affairs (RA) regional leads. Lastly, the role will serve as a point of contact for Global Regulatory Affairs (GRA) for regulatory due diligence requests from Business Development (BD), providing help with coordination and tracking all due diligence requests from BD for GRA.
• This position requires a high level of expertise in regulatory frameworks, industry drivers, regulatory intelligence tools and information sources, and practices. The ideal candidate will take pride in delivering high-quality work and apply extensive knowledge of regulatory frameworks to develop innovative approaches and provide actionable insights to internal stakeholders. The primary challenge in this role will be optimizing productivity amidst a diverse and broad remit, requiring flexibility and autonomy. Reporting to the Global Head of GRAPI, the role will have regular formal and informal interactions. Supervisory guidance will be available to support all efforts, while allowing for autonomous work.
  

How You’ll Spend Your Day

• This pivotal role will be responsible for orchestrating a world-class regulatory intelligence and research function that goes beyond reporting to provide forward-looking strategic foresight.
• Willingness to travel as required for cross-functional customer meetings, industry events, and other business engagements.
• Willingness to work across time zones and flexibility with working hours. The role is part of a global team with members based in USA and Europe.
• Support the high-performance GRAPI team with deep regulatory expertise and innovative thinking by proactively anticipating, identifying, interpreting, analyzing, synthesizing, and contextualizing emerging regulatory changes and trends across multiple jurisdictions and key markets globally (including but not limited to US, EU, China, Japan, Canada).
• Engages with GRAPI colleagues and IM RA teams and IM regulatory health authorities, industry, and professional association leaders at the policy level; leverages understanding of regulatory health authorities, industry trade associations, and other relevant organizations, to advance Teva’s position related to regulatory policy in key IMs.
• Cultivates internal cross-functional partnerships and provides partners (including, e.g., US and EU GRAPI partners, GRA, Government Affairs, R&D, Medical, Safety, Legal) with a strategic regulatory policy and intelligence perspective.
• Create frameworks for transforming complex regulatory data into high-value, actionable intelligence to inform strategic decision-making.
• Build adaptive research capabilities that can rapidly respond to dynamic regulatory environments.
• Cultivate a culture of continuous learning, intellectual curiosity, and regulatory intelligence.
• Coach and develop cross-functional colleagues working on developing regulatory strategy for Teva development programs to become world-class experts in regulatory interpretation and analysis.
  

JD To Be Contd.
Other Internal responsibilities:

• Contribute to GRAPI weekly newsletter by providing content support for international markets (ex-US and ex-EU) and editorial input.
• Contribute to internal training materials, educating cross-functional teams on regulatory trends and analysis.
• Stay abreast of regulatory changes by regularly consuming and filtering relevant news sources and disseminating insights across the organization.
• Participate in Executive Briefings, collaborating on workshops and team discussions.
  

Other External Responsibilities

• Host and lead industry roundtables, facilitating discussions on evolving regulatory practices and attending social events to engage with key opinion leaders and stakeholders for key IM Markets to develop Teva influence currency for shaping the regulatory policy landscape.
• Speak on panels and as a keynote speaker at industry events, representing Teva GRAPI team, and enhancing GRAPI function’s external engagement footprint.
• Support the GRAPI and IM RA teams in their engagement with regulators from key IMs to sensitively and diplomatically advocate for Teva’s regulatory policy priorities and positions to offer pragmatic solutions and alleviate regulatory challenges.
  

Key Responsibilities

• Develop and implement a comprehensive regulatory intelligence strategy and practice that positions GRAPI as the premier thought leader in regulatory insights.
• Develop and implement system to track and service internal regulatory intelligence queries in a timely manner and with actionable intelligence and analysis.
• Serve as point of contact for coordinating all regulatory due diligence requests from BD for GRA.
• Provide regulatory policy support for key IMs RA regional leads as aligned with the Head of GRAPI and VP for IM RA.
  

Your Experience And Qualifications

• Post-graduate (Master’s or PhD) degree in a relevant field required. Advanced degree preferred. Additional certifications (e.g., RAC) would be a plus.
• 10+ years of overall work experience, preferably in regulatory affairs, 3+ years of experience in regulatory policy or intelligence roles desired. At minimum, experience within regulatory roles in the pharmaceutical / regulatory intelligence services industry, with a demonstrated understanding of regulatory frameworks of global health authorities.
• Familiarity with common databases like Citeline, Evaluate, Cortellis, IQVIA, Redica, etc.
• Strong communication skills, both written and verbal, with the ability to articulate complex regulatory concepts clearly and persuasively.

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  Get Hired
  Knowledge and use of regulatory intelligence tools to monitor, analyze, and anticipate changes in the regulatory environment and service internal regulatory intelligence queries.
• Experience with relevant IT or regulatory IT tools and approaches (e.g., Artificial Intelligence, automation, bots, etc.) to assist with regulatory intelligence gathering.
• Experience in regulatory policy development with comprehensive knowledge of biopharmaceutical industry. Experience in building relationships with key stakeholders (e.g., trade associations, biopharmaceutical companies, health authorities, etc.).
• Proven track record of developing innovative regulatory intelligence, gathering, research, and impact analysis methodologies. Strong ability to source and analyze regulatory intelligence and research data to inform / drive regulatory strategies and decisions.
• Exceptional ability to translate complex regulatory information into strategic insights. Advanced analytical skills with a demonstrated capacity to “connect the dots” such as between a regulatory intelligence information update and what it may mean for a development program or for the organization at large.
• Adaptable and resilient in fast-evolving regulatory landscapes.
  

Preferred Skills

• Strong presentation, oral, written, and interpersonal communication skills.
• A strategic mindset that transforms regulatory information into competitive advantage.
• Insight to deal with ambiguity, as well as a rapid pace of work.
• Being detail-oriented with a demonstrated ability to self-motivate and follow through on projects.
• Sound business judgment, proven ability to influence others, and strong strategic and analytical thinking skills are critical to success in this position.
• Strong executive presence with the credibility to engage at all organizational levels.
• Strategically minded, with the ability to see beyond immediate challenges.
• Committed to excellence and continuous improvement.
• The ability to tell compelling stories through data and insight.
• Experience with program/project management skills would be beneficial, including the ability to manage multiple projects simultaneously and drive them to successful completion.
• Ability to work autonomously as well as collaboratively within a cross-functional team environment, demonstrating flexibility and adaptability to changing priorities.
• Collaborative yet decisive in driving regulatory research excellence.
  

Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas 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.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.