Global Regulatory Strategy Lead

vor 1 Monat

Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

**The Position**:
We are seeking a dynamic individual to provide global strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects in the Therapeutic Area of CNS, Retinal Health & Emerging Areas (CREA). In this pivotal role, you will develop and be accountable for the Global Regulatory Strategy of your projects lead the Regulatory Excellence Team (RET), and represent Global Regulatory Affairs (GRA) on the Evidence Team (aka the cross-functional project Team).

This position can be filled in Germany (Ingelheim) or the US.

***Tasks & responsibilities**:

- As a regulatory professional, you will contribute to a holistic global strategy for assigned CREA projects. Your leadership and in-depth expertise will enable you to interact seamlessly at all levels of the organization, drive project goals, and maintain the highest standards of professionalism, ethics, and regulatory compliance.
- You will lead the development and implementation of cutting-edge global strategic regulatory strategies. Your role will involve assessing regulatory risks, proposing innovative solutions, and collaborating closely with stakeholders to align regulatory strategies with business objectives.
- As the main GRA representative on the Evidence Team, you will ensure that regulatory considerations are incorporated timely and comprehensively in the decision-making process.
- You will lead the Regulatory Excellence Team (RET) for assigned projects, fostering a culture of excellence and continuous learning. Your role will involve mentoring team members, identifying training needs, and promoting a proactive and solution-oriented approach.
- In collaboration with Asset & Evidence teams and Global Labelling, you will shape early target label profiles and oversee the planning, preparation, and execution of regulatory submissions. Your role will also involve supporting submission rollout for Rest of World (RoW) countries from a global strategic perspective.
- As a regulatory intelligence expert, you will stay up-to-date with relevant worldwide regulations and guidelines. Your role will involve evaluating evolving regulatory trends, providing timely risk/benefit analyses, and developing contingency plans for assigned projects.

***Requirements**:

- High level of education in pharmacy, life sciences, or chemistry, ideally holding a Master's or Doctoral Degree. Additional certifications such as Specialized Pharmacist, Master of Drug Regulatory Affairs, or RAC are highly desirable.
- In-depth knowledge of Regulatory Affairs across multiple regions, including the US and/or EU. You have a proven track record of developing and implementing successful regulatory strategies, ideally with preparation of IND, (s)BLA/(s)NDA and/or MAA, Health Authority meeting briefing documents and negotiating with Health Authority(ies) in a major market (e.g. US, EU).
- Regulatory experience in CREA diseases is preferred, and experience outside of Regulatory Affairs in R&D will be considered a valuable asset.
- Proven ability to interpret and translate complex scientific data and regulatory guidelines into project-specific proposals. You should have a commercial awareness and a thorough understanding of the business environment.
- Strong critical thinking and strategic mindset, with the ability to anticipate both opportunities and challenges in execution. You should excel at problem-solving, decision-making, and developing realistic action plans to achieve specific goals.
- Excellent leadership and team management skills, with the ability to influence, lead, and inspire cross-functional teams. You should have strong interpersonal skills, relationship building, and conflict management skills.

***Ready to contact us?**:
If you have any questions about the job posting or process - please contact our HR Direct Team,

Recruitment process:
Step 2: Virtual meeting starting in the middle of May 2024

Step 3: On-site interviews starting at the end of May 2024

  • Global Regulatory Strategy Lead

    vor 4 Wochen

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: We are seeking a dynamic individual to provide global strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects in the Therapeutic Area of Cardiovascular, Renal and Metabolic diseases (CRM). In this pivotal role, you will develop and be accountable for the Global Regulatory Strategy of your projects...

  • Capability Lead Ra Regions

    vor 1 Monat

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: Welcome to a dynamic and global role that sits at the heart of Regulatory Affairs (RA). Reporting directly to a Team Lead for Regulatory Excellence, this position offers a unique opportunity to lead and shape the future of our regulatory processes and technologies. You will lead a Capability Area or a standalone Project, you will be...

  • Global Regulatory Change and Controls-emerging

    vor 1 Monat

    Frankfurt am Main, Deutschland JPMorgan Chase Bank, N.A. Vollzeit

    **CIB Operations - Global Regulatory Change and Controls - Working Student (M/F/d) Frankfurt** **Our Business**: The CIB Global Regulatory Change and Controls (GRC&C) team is part of the wider CIB Operations department and have responsibility for providing oversight, leadership and management across the global CIB regulatory landscape. The remit covers...

  • Regulatory Affairs Manager

    Vor 4 Tagen

    Frankfurt, Deutschland Biocon Biologics Vollzeit

    About the company:At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We have a long-term...

  • Regulatory Strategy Officer

    vor 1 Monat

    Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit

    **JOB DESCRIPTION** **Posting description** The role sits within the Corporate & Investment Bank Compliance team and works closely with the EMEA Regulatory Management team (part of the broader EMEA Compliance Department) responsible for the oversight and coordination of engagement with J.P. Morgan SE (JPMSE) regulators. **Responsibilities**: The role...

  • Senior Clinical Program Lead

    vor 1 Monat

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: Are you a passionate and experienced Retinal Specialist looking to take your career to the next level? Do you want to be at the forefront of clinical research and development, driving patient value and quality of life outcomes? If so, we have an exciting opportunity for you! Boehringer Ingelheim is seeking a dedicated and innovative...

  • Global Alliance Lead

    vor 1 Monat

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    The Position We are seeking a highly experienced and strategic professional to join our team as a Global Alliance Lead (GAL) in the Human Pharma segment. The GAL plays a crucial role in driving the success of Boehringer Ingelheim by leading complex, high-value strategic alliances, which are becoming a core value driver for our organization. As a GAL, you...

  • Werkstudent in

    vor 1 Monat

    Frankfurt am Main, Deutschland Deutsche Börse Vollzeit

    **Learn. Develop. Grow. But always: Share value**: Werden Sie Teil unserer internationalen Teams, die positiven Wandel vorantreiben - vereint durch Aufgeschlossenheit und Neugierde. Bei uns dürfen Sie etwas bewirken und gleichzeitig wachsen - persönlich und beruflich. Bei uns arbeiten Sie im Herzen der Finanzwirtschaft und entwickeln funktionierende...

  • Global Team Lead Data Strategy

    vor 1 Monat

    Frankfurt am Main, Deutschland KION Information Management Services GmbH Vollzeit

    Für einen unserer Standorte in Frankfurt am Main, Aschaffenburg oder Hamburg suchen wir Dich als Global Team Lead Data Strategy & Adhoc/Analytics (w/w/d)! **What we offer**: - **Ein Unternehmen mit Zukunft**:Schon heute beschäftigen wir als börsennotiertes M-Dax Unternehmen mehr als 41.000 MitarbeiterInnen in über 100 Ländern und treiben damit...

  • Global Coalition Lead

    vor 1 Monat

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **Tasks & responsibilities**: - In this role, you will crystallize the vision, strategy and mission and champion the coalition and its unique contribution to affecting positive changes to PF healthcare delivery system.- - You will cultivate strong partnerships with coalition partners and spearhead internal and external processes to mobilize the right...

  • Intern - Regulatory Strategy (F/m/d)

    Vor 4 Tagen

    Frankfurt am Main, Deutschland Deutsche Börse Vollzeit

    **Learn. Develop. Grow. But always: Share value**: Join our international team that drives positive change, united by a spirit of openness and curiosity. We empower you to have an impact and to grow - personally and professionally. With us, you work at the heart of financial systems and evolve the way markets operate. We’re excited about the future because...

  • Chief of Staff

    vor 1 Monat

    Frankfurt am Main, Deutschland NTT Global Data Centers EMEA GmbH Vollzeit

    The **Chief of Staff (M/F/d)** serves as a central point of contact for the CRO and internal and external stakeholders to establish clarity and communication across all aspects of the NTT GDC, Global Data Center Corporation, and NTT Limited (when required). This highly visible role drives the rhythm of business for sales and is responsible for ensuring that...

  • Working Student

    Vor 7 Tagen

    Frankfurt am Main, Deutschland Deutsche Börse Vollzeit

    **Learn. Develop. Grow. But always: Share value**: Join our international team that drives positive change, united by a spirit of openness and curiosity. We empower you to have an impact and to grow - personally and professionally. With us, you work at the heart of financial systems and evolve the way markets operate. We’re excited about the future because...

  • Working Student

    Vor 4 Tagen

    Frankfurt am Main, Deutschland Deutsche Börse Vollzeit

    **Learn. Develop. Grow. But always: Share value**: Join our international team that drives positive change, united by a spirit of openness and curiosity. We empower you to have an impact and to grow - personally and professionally. With us, you work at the heart of financial systems and evolve the way markets operate. We’re excited about the future because...

  • Working Student

    Vor 3 Tagen

    Frankfurt am Main, Deutschland Deutsche Börse Vollzeit

    **Learn. Develop. Grow. But always: Share value**: Join our international team that drives positive change, united by a spirit of openness and curiosity. We empower you to have an impact and to grow - personally and professionally. With us, you work at the heart of financial systems and evolve the way markets operate. We’re excited about the future because...

  • Director Regulatory Information Management

    vor 4 Wochen

    Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    **In your role as** Director Regulatory Information Management (M/F/d) you will be responsible for provision of information on regulatory status (registrations) for all Care Enablement products including regulatory KPIs. **Your assignments** - Implementation and maintenance of a registration information management system (RIMS) including a process to steer...

  • Director & Head of Quality & Regulatory Country Hub

    vor 1 Monat

    Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    Establish, implement and lead regulatory and quality strategies to actively support Fresenius Medical Care's Business in adequate time and way. Ensure product safety, quality and regulatory compliance in accordance with applicable laws and standards in all countries in scope of the hub. **Your assignments**: - Establish QR structures, national teams to...

  • Risk, Regulatory Engagement, Analyst, Frankfurt

    Vor 4 Tagen

    Frankfurt am Main, Deutschland Goldman Sachs Vollzeit

    Regulatory Engagement - Analyst, Frankfurt YOUR IMPACT As a member of the Risk Division's Regulatory Engagement team in Frankfurt, you will play a key role in the oversight and implementation of relevant risk management regulation and processes across risk functions, as well as regional and legal entity governance in the EMEA region. You will be...

  • Lead / Principle Project Manager - IT Strategy & Innovation

    vor 1 Monat

    Frankfurt am Main, Hessen, Deutschland Commerzbank AG Deutschland Vollzeit

    Lead / Principle Project Manager - IT Strategy & Innovation (m/w/divers) Tätigkeitsfeld: Strategie / Analyse / Consulting Art der Stelle: Unbefristet / Vollzeit / Teilzeit Standort: Frankfurt am Main Datum des ersten Arbeitstages: ab sofort Datum des Einsendeschlusses: Dich fasziniert das Zusammenspiel von Technologie, Strategie und Innovation? Dann...

  • Fig Market Development

    vor 1 Monat

    Frankfurt am Main, Deutschland S&P Global Vollzeit

    -S&P Global Frankfurt am Main, Germany Posted 1 hour ago Permanent Competitive - FIG Market Development - Non-US Lead**S&P Global Market Intelligence** **The Role**: FIG Market Development, Non-US Lead**The Team**: The FIG business line is our premiere deep sector data covering the financial institutions space, with rich coverage of banks, insurance...