Current jobs related to Global Regulatory Lead - Raleigh, North Carolina - UCB

  • VP, Global Regulatory Operations Lead

    3 days ago

    Raleigh, North Carolina, United States Bandwidth Inc. Full time

    Job Title: VP, Global Regulatory OperationsAbout Us:Bandwidth Inc. is a leading provider of messaging, voice, and emergency service connectivity for top-tier brands. We deliver world-class communications services through our global network and enterprise-grade APIs.Job Summary:We seek a highly experienced VP, Global Regulatory Operations to lead our...

  • Regulatory Policy Counsel

    2 weeks ago

    Raleigh, North Carolina, United States Bandwidth Inc. Full time

    About the RoleWe are seeking a highly skilled Regulatory Policy Counsel to join our team at Bandwidth Inc. as a key member of our global communications regulatory and public policy initiatives.Key ResponsibilitiesSupport Bandwidth's public policy advocacy efforts at the Federal Communications Commission, state public utility commissions, and international...

  • Regulatory Affairs Manager

    2 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Regulatory Affairs Labeling ManagerProclinical Staffing is seeking a skilled Regulatory Affairs Labeling Manager to join a global biopharmaceutical company with locations in the US.Key Responsibilities:The successful candidate will lead the development of new labeling content in collaboration with cross-functional project teams. They will manage the creation...

  • Regulatory Affairs Manager

    2 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Regulatory Affairs Labeling ManagerProclinical Staffing is seeking a skilled Regulatory Affairs Labeling Manager to join a global biopharmaceutical company with locations in the US.Key Responsibilities:The successful candidate will lead the development of new labeling content in collaboration with cross-functional project teams. They will manage the creation...

  • Regulatory Affairs Manager

    2 days ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Job Title: Manager, Regulatory Affairs LabelingProclinical is seeking a skilled Manager, Regulatory Affairs Labeling to join a global biopharmaceutical company with locations in Georgia, North Carolina, and Massachusetts.Job Summary:The Manager, Regulatory Affairs Labeling will lead the development of new labeling content in collaboration with a...

  • Lead Regulatory Affairs Specialist

    1 month ago

    Raleigh, North Carolina, United States UL Full time

    Position Overview:The Lead Regulatory Affairs Specialist at UL, LLC plays a pivotal role in navigating Canadian regulatory frameworks. This position is tasked with identifying, gathering, and analyzing scientific reports, data, and regulations to prepare essential documentation for governmental bodies. Additionally, the specialist curates and develops...

  • Regulatory Compliance Engineer

    4 weeks ago

    Raleigh, North Carolina, United States Lotustg Full time

    Job Title: Regulatory Compliance EngineerSelect employment type: Contract (C2C/ W2/ 1099)/FulltimeAbout the client:Lotustg is a prominent player in Engineering and R&D (ER&D) services. With numerous patents filed for leading global ER&D spenders, Lotustg is at the forefront of engineering innovation. Their groundbreaking projects include advanced robotics,...

  • Federal Regulatory Manager

    3 weeks ago

    Raleigh, North Carolina, United States ADAMA Ltd. Full time

    Job SummaryWe are seeking a highly skilled Federal Regulatory Manager to join our team at ADAMA Ltd. The successful candidate will be responsible for ensuring that our products meet the required legislation and regulations in the US market.Key ResponsibilitiesDevelop Regulatory Strategies: Develop and implement regulatory strategies for designated active...

  • Federal Regulatory Specialist

    2 weeks ago

    Raleigh, North Carolina, United States ADAMA Ltd. Full time

    About the RoleWe are seeking a highly skilled Federal Regulatory Manager to join our team at ADAMA Ltd. This role will be responsible for ensuring our products meet required legislation and regulations.Key ResponsibilitiesDevelop and implement regulatory strategies for designated active ingredients and products.Process submissions according to agreed project...

  • Global Alliance Lead

    2 weeks ago

    Raleigh, North Carolina, United States Juniper Networks Full time

    Job DescriptionThis is a senior-level role that requires a strong background in sales and alliance management. The ideal candidate will have extensive experience in leading solution sales business in Enterprise and Telco accounts, with a focus on Hybrid Cloud/Multicloud, AI driven Enterprise, Security, and Managed services.Key ResponsibilitiesDevelop and...

  • Architectural Design Lead

    6 days ago

    Raleigh, North Carolina, United States Insight Global Full time

    Job OpportunityJob Title: Architectural Design LeadCompany: Insight GlobalLocation: Raleigh, NCJob Type: Full-timeAbout the Role:We are seeking an experienced Architectural Design Lead to join our team in Raleigh, NC. As a key member of our engineering consulting firm, you will be responsible for leading large project teams and overseeing the production of...

  • Regulatory Policy Counsel

    2 weeks ago

    Raleigh, North Carolina, United States Bandwidth Inc. Full time

    Job SummaryThe Regulatory Policy Counsel will work closely with internal and external stakeholders to develop and advocate public policy positions that support Bandwidth's business strategies. This role is responsible for supporting a wide range of global communications regulatory and public policy initiatives and advocacy.Key Responsibilities• Support...

  • Director, Regulatory Affairs Specialist, Advertising and Promotion

    2 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Job Summary:Proclinical Staffing is seeking a highly experienced Regulatory Affairs Director to lead the development and implementation of promotional and advertising strategies for a large global pharmaceutical company.Key Responsibilities:Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product...

  • AV Installation Technician Lead

    3 weeks ago

    Raleigh, North Carolina, United States Insight Global Full time

    Job SummaryWe are seeking a highly skilled AV Installation Technician Lead to join our team at Insight Global. As a key member of our technical team, you will be responsible for leading the installation, troubleshooting, and maintenance of complex audio/visual systems.Key ResponsibilitiesLead the installation of audio/visual systems, ensuring top-notch...

  • Architectural Design Lead

    2 weeks ago

    Raleigh, North Carolina, United States Insight Global Full time

    Job OverviewInsight Global is seeking an experienced Architectural/BIM Design Lead to join our team in Raleigh, NC. As a key member of our engineering consulting firm, you will be responsible for leading large project teams and overseeing the production of architectural construction documents.Key Responsibilities:Develop and implement architectural design...

  • Regulatory Affairs Director

    4 days ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Regulatory Affairs Director - US Advertising and PromotionProclinical Staffing is seeking a highly skilled Regulatory Affairs Director to lead our client's US advertising and promotion efforts. As a key member of the team, you will be responsible for ensuring compliance with FDA regulations and industry guidelines.Key Responsibilities:Provide regulatory...

  • R&D Global Program Manager

    2 weeks ago

    Raleigh, North Carolina, United States Veeva Systems Full time

    About the RoleVeeva Systems is a pioneering organization in industry cloud, dedicated to helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we have surpassed $2B in revenue in our last fiscal year, with extensive growth potential ahead.Key ResponsibilitiesLead Vault implementation...

  • Risk Management Specialist

    3 weeks ago

    Raleigh, North Carolina, United States Global Channel Management Full time

    About the role at Global Channel Management: **Bank Risk Manager** is a critical position that requires a unique blend of skills and expertise. **Key Responsibilities:** • **Contract Negotiation**: Negotiate contracts with business partners to ensure standard terms and conditions are included, aligning with the bank's risk framework. • **Risk...

  • Regulatory Compliance Specialist

    1 month ago

    Raleigh, North Carolina, United States Hired by Matrix Full time

    Job OverviewKey Responsibilities:Assist in the global registration of pesticides by preparing various certificates and official documents.Oversee and ensure the timely processing of these certificates through different governmental bodies.Manage the design and layout of pesticide labels for business-to-business (B2B) applications.Keep precise records and...

  • Audit Manager

    2 days ago

    Raleigh, North Carolina, United States RSM Global Full time

    Job Title: Audit ManagerWe are seeking a highly skilled and experienced Audit Manager to join our Assurance Life Sciences practice at RSM Global. As a key member of our team, you will be responsible for leading audits of life science companies and related organizations, ensuring the highest level of quality and professionalism.Responsibilities:Lead audits of...

Global Regulatory Lead

3 months ago

Raleigh, North Carolina, United States UCB Full time

Make your mark for patients

We 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 role

The Global Regulatory Affairs Leader (GRL) provides regulatory leadership to assigned Mission and/or asset. The GRL leads the global Regulatory Strategic Team (RST) for assigned projects. This role will be accountable for the global regulatory strategy and oversight of implementation/execution in alignment with the Regional Regulatory Leads and other RST members.

The GRL is the primary contact point within UCB for any regulatory questions related to the assigned Mission and/or asset and is informed of and supports any key (planned) interactions with health authorities. The role is also responsible for leading and coordinating Mission regulatory budget and Practice resource discussions on behalf of the PVU and the GRA practice for assigned projects.

Who you'll work with

You will report into the Head of EU Regulatory Affairs

What you'll do

  • Serve as the Regulatory point of contact on the assigned Mission/PST with senior management and/or at other internal meetings providing the agreed global regulatory strategic recommendations and risk assessment for key projects.
  • May serve as the Global Regulatory representative on other relevant governance teams representing the agreed global regulatory functional view.
  • Accountable for the timely development and implementation of the global regulatory strategy and plan(s) designed to meet the needs of the business and patients for assigned Missions and/or projects (to deliver timely product milestones (e.g. HA meetings, new indications, etc.), ultimately leading to approval with a viable label meeting the needs of patients and the business).
  • Accountable for delivering all regulatory milestones related to the assigned Mission including assessment of the approvability of the program submissions together with global regulatory risk mitigation measures (supported by the regions as appropriate).
  • Accountable for the review of global/regional submission key documents (as applicable) and ensuring global alignment of key messages in line with Mission/PST objectives.
  • Identify any potential risks along with possible contingencies to ensure the most appropriate submission timing leading to the earliest possible and most optimal approval of key deliverables.
  • Accountable for ensuring the regional regulatory strategy for the specific product(s) are consistent with the business objectives, have been negotiated (if appropriate) with the appropriate regulatory authorities and that the regulatory risks have been identified.

Interested? For this position you'll need the following education, experience and skills:

  • Bachelor's degree
  • Several years' experience in pharmaceutical regulatory affairs.
  • Knowledge of global regulatory procedures and legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension and license maintenance. Global regulatory experience is a plus.
  • Global and integrated cross-functional view into pharmaceutical project management and drug development/approval and commercialization. Ability to appreciate multiple cross-functional elements contributing within drug development and ability to develop an adequate and coherent supportive global/local regulatory strategy.
  • Good track record of (contributing to) delivering regulatory approvals.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US- for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Requisition ID: 87817

Recruiter: Chris Venegas

Hiring Manager: Susanne Barbara Dorn

Talent Partner: Geraldine Beauduin

Job Level: SM II

Please consult HRAnswers for more information on job levels.