Director International Regulatory Affairs Planning

7 maanden geleden

Amsterdam, Nederland Regeneron Pharmaceuticals Inc. Voltijd

The Director of Planning and Strategy works in lockstep with the Head of International Regulatory Affairs to drive strategic planning and operations for the function, and to advance the objectives and vision of the Regulatory Leadership. This includes ensuring project support and oversight for complex programs in the region while also coordinating meeting agendas and tracking of required actions until completion. Reviewing internal strategic and operational deliverables, coordination of monthly reporting, resource management, and organizational development will also be in scope. A further key aspect will include seeking key opportunities for cross-functional optimization.

**JOB RESPONSIBILITIES**:
Serve as a strategic thought partner to the Head, International Regulatory Affairs regarding future initiatives, strategies, project management and organizational efficiency.

Ensure project management support and facilitation of specific projects with the coordination of the preparation of cross-functional meetings and tracking of required deliverables until completion.

Monitor progress toward functional goals, to ensure that the department remains on track to meet or exceed its performance targets.

Contribute to process optimization projects, with a focus on initiatives directed towards productivity, efficiency, effectiveness.

Successfully oversee, lead and deliver operational optimization improvements bringing ideas and visions that can complement the existing infrastructure.

Support the International/EU Regulatory function in management of departmental monthly meetings and agenda development and follow-up on actions.

Take a lead role in the reporting of monthly accomplishments for senior management.

Coordinate functional communications as needed.

Enable enhanced methods of resource management by facilitating planning for headcount needs, both for permanent and for contract staff.

Build and maintain cross-functional interfaces with other key functions and stakeholders (e.g., Commercial, Legal, Government Affairs, HR Partners, GPS, Quality, Clinical Development, etc.).

Prepare presentations for Head of International Regulatory Affairs, covering key communications for the Regeneron Ireland BOD, internal collaborators and external parties as needed.

**Experience and Required Skills**:
10+ years of industry experience, advanced degree preferred.

A demonstrated ability to drive project execution and to operate independently and proactively to achieve necessary outcomes.

Skilled in a variety of communication modes

An ability to build strong partnerships throughout the organization developing relationships, both formal and informal to help achieve results.

Comfortable operating across all levels of the organization.

Experience in organization models and development would be an advantage.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

  • Manager Regulatory Affairs

    4 maanden geleden

    Amsterdam, Nederland Sanquin Voltijd

    **Locatie** - Amsterdam **Werkweek** - 32-36 uur **Opleiding** - HBO **Sluitingsdatum** - 18 oktober 2024 **Functiegebied** - QA **Vacature nr.** - 1223 **Manager Regulatory Affairs & Compliance** De QRC afdeling van Sanquin zoekt een Manager Regulatory Affairs & Compliance voor 36 uur per week, die ervoor zorgt dat patiënten altijd en overal kunnen...

  • Adviseur Regulatory Affairs

    2 maanden geleden

    Amsterdam, Heerlen, NL Legal People Voltijd

    ABP is een organisatie met impact en maatschappelijke relevantie. 1 op de 6 mensen in Nederland ontvangt nu of in de toekomst pensioen van ABP. Het beheert meer dan 500 miljard euro voor de werknemers van meer dan 3000 aangesloten werkgevers. ABP streeft duurzame beleggingen na en bouwt daarmee aan een goed pensioen in een leefbare wereld. Dat doet ABP op...

  • Associate Director, International Supply Chain

    3 maanden geleden

    Amsterdam, Nederland Blueprint Medicines Voltijd

    **Location(s)**:Netherlands or Switzerland **Level of position**:Associate Director **Position type**:office-based **Reporting Line**: Director, International Supply Chain **How will your role help us transform hope into reality?** The Associate Director, International Supply Chain will lead the partnerships with external partners for commercial...

  • Associate Director, Regulatory Affairs

    3 maanden geleden

    Amsterdam, Nederland Regeneron Pharmaceuticals Inc. Voltijd

    The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin or Amsterdam office. The role is positioned at the Associate Director level to enable independent working and leadership in direct...

  • Director Sustainable Public Affairs

    2 maanden geleden

    Amsterdam, Nederland Avantium Voltijd

    **Department**: - Renewable Polymers**Office**: - Headquarters**Location**: Amsterdam **Director Sustainable Public Affairs - Policies**: **Who are we?** Our world needs solutions, and we need them fast. A growing population and increasing standards of living drive our energy and material consumption. In order to keep global warming at bay, we need to...

  • Medewerker Regulatory Affairs

    2 maanden geleden

    Amsterdam, Nederland Holland & Barrett Voltijd

    Hou jij ervan om in de wet te duiken en zaken tot op de bodem uit te zoeken? Zorg jij er graag voor dat producten voldoen aan de geldende wet - en regelgeving? In deze baan ga je aan de slag met Regulatory Affairs voor het zeer uiteenlopende assortiment van Holland & Barrett, zoals voedingssupplementen, sportvoeding en beauty producten. Dit doe je voor...

  • Director Sustainable Public Affairs

    2 maanden geleden

    Amsterdam, Nederland Avantium Voltijd

    **Who are we?** Our world needs solutions, and we need them fast. A growing population and increasing standards of living drive our energy and material consumption. In order to keep global warming at bay, we need to reduce our carbon footprint substantially, in fact transition towards a climate neutral economy. Avantium's Vision: "We believe in a...

  • Regulatory Affairs Specialist Met een Brede Expertise

    3 weken geleden

    Amsterdam, Noord-Holland, Nederland Legal People Voltijd

    Pensioenbelegger met Duurzame AmbitiesABP is een organisatie die impact heeft en maatschappelijke relevantie in Nederland. Meer dan 6 miljoen mensen ontvangen nu of in de toekomst pensioen van ABP, waarmee het een belangrijke rol speelt in de financiële sector.BedrijfsprofielAls werkgever streeft ABP naar duurzame beleggingen om zo aan te dragen bij een...

  • Regulatory Affairs Manager Bloedproducten

    4 maanden geleden

    Amsterdam, Nederland Sanquin Voltijd

    **Locatie** - Amsterdam **Werkweek** - 32-36 uur **Opleiding** - HBO **Sluitingsdatum** - 16 oktober 2024 **Functiegebied** - QA **Vacature nr.** - 1218 **De QRC afdeling van Sanquin zoekt een RA Manager voor 36 uur per week, die ervoor zorgt dat patiënten altijd en overal kunnen rekenen op veilige bloedproducten.** **Waar kom je te werken** Als RA...

  • Head of Licensing and Regulatory Affairs

    3 maanden geleden

    Amsterdam, Nederland Adyen Voltijd

    **This is Adyen** Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition. For our teams, we create an environment with opportunities for our people to succeed, backed by the...

  • Legal Counsel Regulatory Affairs

    4 weken geleden

    Amsterdam, Nederland Yoursafe Voltijd

    Ter versterking van ons juridische team zijn we op zoek naar een **Legal Counsel Regulatory Affairs** **(40 uur per week)** **Over Yoursafe** Yoursafe is een Elektronische Geldinstelling (EGI) met een vergunning van De Nederlandsche Bank. Wij zetten ons in om individuen en bedrijven wereldwijd te ondersteunen in financiële vrijheid en authenticiteit....

  • Director - Public Affairs

    7 maanden geleden

    Amsterdam, Nederland Gilead Sciences Voltijd

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies...

  • Head of licensing and regulatory affairs

    1 dag geleden

    Amsterdam, Nederland Adyen Voltijd

    Head of Licensing and Regulatory Affairs - EMEAThis is AdyenAdyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition.For our teams, we create an environment with opportunities for...

  • Head of Licensing and Regulatory Affairs

    2 dagen geleden

    Amsterdam, Nederland Adyen Voltijd

    Head of Licensing and Regulatory Affairs - EMEARegulatory AmsterdamThis is AdyenAdyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition.For our teams, we create an environment with...

  • Adviseur Regulatory

    2 maanden geleden

    Amsterdam West, Nederland CompliancePeople Voltijd

    **Jasper den Ouden**: - Consultant Executive Search_ 020-6125522ABP is een organisatie met impact en maatschappelijke relevantie. 1 op de 6 mensen in Nederland ontvangt nu of in de toekomst pensioen van ABP. Het beheert meer dan 500 miljard euro voor de werknemers van meer dan 3000 aangesloten werkgevers. ABP streeft duurzame beleggingen na en bouwt daarmee...

  • Director Regulatory Compliance

    3 maanden geleden

    Amsterdam Centrum, Nederland Booking.com Voltijd

    Role Description: **Director Regulatory Compliance** that the company will not in any way improperly influence the decision-making of the lawyers acting in their capacity as lawyers. **Key Responsibilities** - Maintain and strengthen case-management and investigation protocols with focus on increased efficiencies without sacrificing depth and quality; -...

  • Head of Regulatory Affairs and Sustainability

    1 maand geleden

    Amsterdam-Zuidoost, Nederland Zaffra BV Voltijd

    **Functieomschrijving Hoofd Regulatory Affairs en Duurzaamheid** Zaffra is een onlangs opgerichte Joint Venture tussen wereldwijde partners, Sasol & Topsoe. De missie van Zaffra is om een toonaangevende producent en leverancier van duurzame vliegtuigbrandstof te worden. We investeren in en ontwikkelen projecten gedurende de hele levenscyclus, waarbij we...

  • Internship - Global Governmental & Public Affairs

    3 maanden geleden

    Amsterdam, Nederland Heineken International B.V. Voltijd

    Internship - Global Governmental & Public Affairs The internship You will work alongside the Global Governmental and Public Affairs team, as well as with the local operating companies and colleagues from across the business. Tasks include: monitoring political developments, monitoring tax and/or regulatory developments that might get an impact on our...

  • Internship - Global Government & Public Affairs

    3 maanden geleden

    Amsterdam, Nederland Heineken International B.V. Voltijd

    Internship - Global government & Public Affairs You will work alongside the Global Governmental and Public Affairs team, as well as with the local operating companies and colleagues from across the business. Tasks include: monitoring political developments, monitoring tax and/or regulatory developments that might get an impact on our industry, conducting...

  • Director, International Scientific Communications

    2 weken geleden

    Amsterdam, Nederland Rhythm Pharmaceuticals Voltijd

    **Company Overview** Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We...