Global Regulatory Strategy Lead

vor 1 Woche

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 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 CRM 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 Cardiovascular, Renal and/or Metabolic 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 in the period from end of March until mid of April 2024

Step 3: On-site interviews starting mid of April 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 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...

  • Global Regulatory Lead

    Vor 6 Tagen

    Monheim am Rhein, Nordrhein-Westfalen, Deutschland UCB Vollzeit

    Make your mark for patientsWe are looking for a Global Regulatory Lead to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta or Raleigh (US) offices.About the roleThe Global Regulatory Affairs Leader (GRL) provides regulatory leadership to assigned Mission and/or asset. The GRL leads the global Regulatory...

  • Global Regulatory Affairs Lead

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Affairs Lead (m/w/d) NeurotoxinsView job hereGlobal Regulatory Affairs Lead (m/w/d) NeurotoxinsFull TimeAlfred-Wegener-Straße 2, 60438 Frankfurt am Main, DeutschlandWith Professional Experience3/15/24YOUR CONTRIBUTIONJoin our motivated team in Global Regulatory Affairs - Neurotoxins and grow with exciting challenges. As Global Regulatory...

  • Team Lead

    vor 4 Wochen

    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...

  • Global Head of Labelling

    vor 4 Wochen

    Frankfurt am Main, Deutschland Haybury Vollzeit

    A fantastic new opportunity has been created for a leading, global pharmaceutical company, based in their global headquarters. My client is a market leader, at the frontier of drug research and development, with promising first-in-class and potential medical breakthrough pipeline projects. The Head of the Global Labelling within the Global Regulatory...

  • Regulatory Advisor, Global Regulatory Nutrional

    vor 4 Wochen

    Frankfurt Am Main, Deutschland Elanco Vollzeit

    Education : EQUIVALENTEXPERIENCE **As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance...

  • Regulatory Advisor, Global Regulatory Nutrional

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland Elanco Vollzeit

    Education :EQUIVALENTEXPERIENCEAs a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our...

  • Regulatory Strategy Compliance

    vor 1 Monat

    Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit

    **JOB DESCRIPTION** Regulatory Strategy Compliance - Working Student (all genders) - Emerging Talent Program** We are looking for a highly motivated Working Student (all genders) in Regulatory Strategy Compliance for 19 h/week during the semester, full-time during breaks on-site in Frankfurt, starting from March 2024. The duration of program is one...

  • Global Regulatory Lead

    Vor 3 Tagen

    Frankfurt, Deutschland Merz Therapeutics GmbH Vollzeit

    Join our motivated team in Global Regulatory Affairs - New Assets and grow with exciting challenges. As Global Regulatory Lead (GRL) you are the primary interface and key strategic partner to Global Product Team (GPT) of throughout the product life cycle on New Assets and its maintenance. This will include the following activities:APCT1_DE

  • Regional Regulatory Lead

    vor 4 Wochen

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **Tasks & responsibilities**: - You will plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region. - In collaboration with other departments, you will organize, schedule, and lead a F2F or remote meetings with regulatory authorities in the EUCAN region. - You will proactively contribute as...

  • Capability Lead Ra Regions

    vor 3 Wochen

    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...

  • Regulatory Strategy Compliance

    vor 3 Wochen

    Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit

    **JOB DESCRIPTION** Currently we are looking for a highly motivated Working Student (all genders), who would like to join our Regulatory Strategy Compliance Team in Frankfurt which is also part of the broader EMEA Regulatory Strategy team within the EMEA Compliance Department responsible for the support in oversight and coordination of engagement with J.P....

  • Head of Team Regional Regulatory Leads

    vor 1 Monat

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: You will lead and manage a team of Regional Regulatory Leads (RRL) for EUCAN Region. **Tasks & responsibilities**: - In your role, you will lead and manage a Team of Regional Regulatory Leads responsible for- steering and coordination of regional regulatory activities for the EUCAN region required for development, maintenance, and...

  • Sr Director, Medical Strategy Lead

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

    The IQVIA Cardiovascular Center of Excellence, a hub of clinical innovation, is growing We are looking for exceptional Board-Certified physicians to join our team as a Medical Strategy Lead to help us expand our Cardiovascular portfolio and advance this dynamic and rapidly expanding area of clinical development.The Cardiovascular Medical Strategy Lead is a...

  • Sr Director, Medical Strategy Lead

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

    The IQVIA Cardiovascular Center of Excellence, a hub of clinical innovation, is growing We are looking for exceptional Board-Certified physicians to join our team as a Medical Strategy Lead to help us expand our Cardiovascular portfolio and advance this dynamic and rapidly expanding area of clinical development.The Cardiovascular Medical Strategy Lead is a...

  • Working Student

    vor 3 Wochen

    Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit

    **JOB DESCRIPTION** 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 advocacy, regulatory change, the XODS strategic reporting program and regulatory control framework...

  • Global Regulatory Change and Controls-emerging

    vor 2 Monaten

    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...

  • Head of Team Regional Regulatory Leads

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland BI International GmbH Vollzeit

    The Position:You will lead and manage a team of Regional Regulatory Leads (RRL) for EUCAN Region.Tasks & responsibilities: In your role, you will lead and manage a Team of Regional Regulatory Leads responsible for steering and coordination of regional regulatory activities for the EUCAN region required for development, maintenance, and expansion of worldwide...

  • Regulatory Affairs Manager

    vor 4 Wochen

    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...

  • Head of Global Regulatory Operations

    vor 4 Wochen

    Frankfurt am Main, Deutschland Merz Therapeutics Vollzeit

    **YOUR CONTRIBUTION** As **Head of Global Regulatory Operations** (M/F/d) and member of the Global Regulatory Affairs Leadership Team, you contribute to the development and success of the Merz Therapeutics organization. You lead and develop our Global Regulatory Operations team and be responsible for the management of all activities around the technical...