Regional Regulatory Affairs Team Leader

2 weeks ago

Malvern, Arkansas, United States PharmaLex Full time
Job Overview

The Regional Regulatory Affairs Team Leader for Regulatory Strategy and Procedure Management (SPM) and Regulatory Chemistry, Manufacturing, and Controls (CMC) is responsible for guiding the regional Practice Area teams.


Role Objectives
  • Provide leadership to regional teams focused on Regulatory Strategy and Procedure Management (SPM) and Regulatory CMC.
  • Contribute to the establishment and oversight of the Regulatory Affairs (REG) department within the Value Delivery Centre (VDC) REG, specifically in the SPM and CMC sectors.
  • Manage operational responsibilities arising from global business initiatives, including overseeing significant client projects in regulatory affairs.
  • Drive business development and recruitment efforts in alignment with the global Head of VDC REG and Practice Area Leads.
  • Facilitate growth in the regional regulatory service domain by collaborating with General Managers, Regional Sales Managers, and other Practice Area leads, while promoting cross-selling opportunities.

Main Responsibilities
  • Assist in marketing and business development initiatives for regional clients concerning all existing REG SPM and CMC services.
  • Support Commercial and General Managers in acquiring new clients, including coordinating Requests for Proposals (RfP) and participating in bid defense meetings.
  • Lead major new client programs at the regional/local level, focusing on budget implementation, key performance indicators (KPIs), and project management tasks.
  • Communicate and execute decisions from the REG VDC office within the regional team.
  • Represent departmental interests to the REG VDC office, including managing and reporting on the REG country budget and other financial metrics.
  • Engage in staffing proposals and decisions for regional projects, ensuring optimal utilization of local resources.
  • Oversee the operational direction of the regional Practice Area team.
  • Mentor and guide team members, conducting evaluations and goal-setting meetings as necessary.
  • Foster a leadership culture within the team in collaboration with the REG VDC and General Managers.
  • Act as the representative of the company and department to clients, regulatory authorities, and industry associations.
  • Ensure adequate resource allocation across projects and consistently implement processes within the region.

Key Decision-Making Areas
  • Strategic decisions regarding departmental direction in consultation with the Head of VDC, Practice Area Leads, and Regional General Managers.
  • Initiation of collective agreement actions, such as employment contract terminations, in collaboration with the Head of VDC REG and Human Resources.
  • Evaluation of project approaches and solutions.
  • Budgetary planning for business development activities in partnership with the Commercial team.

Preferred Qualifications and Skills
  • Degree in Life Sciences.
  • A minimum of fifteen years of experience in pharmaceutical regulatory affairs.
  • Demonstrated experience in managing cross-functional and international projects, with a solid understanding of economic principles.
  • Strong leadership capabilities and motivational skills, with prior experience in leading teams.
  • Ability to manage multiple projects simultaneously.
  • Flexibility and willingness to travel as required.
  • Exceptional interpersonal and communication skills, both written and verbal.
  • Confidence to work independently as well as collaboratively.
  • Strategic and analytical mindset with the ability to quickly assimilate and evaluate information.
  • Proficient in problem-solving with a pragmatic approach.
  • Fluency in English.

PharmaLex is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

  • Executive Director, Regulatory Affairs

    1 month ago

    Malvern, Arkansas, United States Venatorx Pharmaceuticals Inc Full time

    Position Description The Executive Director of Regulatory Affairs is responsible for providing overall leadership to ensure the development and execution of regulatory strategies and plans to enable efficient global development of products in the portfolio. (S)he is tasked with providing ongoing analysis of regulatory risks and opportunities in the...

  • Regulatory Affairs Program Manager

    1 month ago

    Malvern, Arkansas, United States Philips Full time

    Job TitleRegulatory Affairs Program ManagerJob DescriptionThe Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes.Your role: Provides Regulatory...

  • Compliance and Regulatory Affairs Coordinator

    2 weeks ago

    Malvern, Arkansas, United States Infinia Search Inc Full time

    Job OverviewThe Compliance and Regulatory Affairs Coordinator plays a crucial role in managing the continuing education (CE) filing and reporting functions for The Institutes. This position encompasses a variety of responsibilities aimed at ensuring compliance with state regulations regarding CE activities.Key ResponsibilitiesPreparation and Submission:...

  • Pharmacovigilance Workstream Lead

    1 week ago

    Malvern, Arkansas, United States PharmaLex Full time

    Job OverviewPharmaLex is seeking a highly skilled and experienced Pharmacovigilance Workstream Lead to join our team. As a key member of our Pharmacovigilance department, you will be responsible for overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team.Key ResponsibilitiesWorkstream Leadership: Responsible and...

  • Pharmacovigilance Workstream Lead

    1 week ago

    Malvern, Arkansas, United States PharmaLex Full time

    Job SummaryPharmaLex is seeking a highly skilled and experienced Pharmacovigilance Workstream Lead to join our team. As a key member of our Pharmacovigilance department, you will be responsible for overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team.Key ResponsibilitiesWorkstream Leadership: Responsible and...

  • Disputes Manager

    3 days ago

    Malvern, Arkansas, United States BM Technologies, Inc. Full time

    Job DescriptionCompany OverviewBM Technologies, Inc. is a leading Banking-as-a-Service (BaaS) provider, offering a range of financial products and services to millions of Americans. Our mission is to provide a more affordable, transparent, and consumer-friendly banking experience.About the RoleWe are seeking an experienced professional to lead our Regulation...

  • Regional Service Technician

    5 days ago

    Malvern, Arkansas, United States Paradise Management Full time

    Job SummaryWe are seeking a highly skilled and experienced Regional Service Technician to join our team at Paradise Management, LLC. As a key member of our maintenance team, you will be responsible for ensuring the smooth operation of our properties and providing exceptional service to our residents.Key ResponsibilitiesConduct regular property inspections to...

  • Public Sector Sales Leader

    2 weeks ago

    Malvern, Arkansas, United States Siemens Medical Solutions USA, Inc. Full time

    Join Siemens Medical Solutions USA, Inc. in our mission to combat some of the world's most pressing health challenges and enhance access to healthcare for individuals globally.About Us: At Siemens Healthineers, we are at the forefront of healthcare innovation. Our commitment is to provide transformative solutions that improve patient outcomes and experiences...

  • Product Information Management Leader

    1 week ago

    Malvern, Arkansas, United States Saint-Gobain North America Full time

    Become a Key Player as the Product Information Management Leader at Saint-Gobain North AmericaThe Product Information Management Leader is essential to the Marketing division at Saint-Gobain, taking charge of product data and digital resources. This role involves close collaboration with IT and various business units, leading a dedicated team that manages...

  • Regulatory Compliance Expert

    5 days ago

    Malvern, Arkansas, United States BM Technologies, Inc. Full time

    Job SummaryWe are seeking a highly motivated and results-driven Senior Compliance Risk Analyst to join our Compliance Monitoring and Testing Team within the Compliance business unit at BM Technologies, Inc. The successful candidate will report to the Compliance Monitoring and Testing Manager and will be responsible for participating in the execution of...

  • Regional Sales Representative

    3 days ago

    Malvern, Arkansas, United States Alumaweld Inc Full time

    Job SummaryWe are seeking a highly motivated and results-driven Inside Sales Representative to join our team at Alumaweld Inc. As a key member of our sales team, you will be responsible for building and maintaining strong dealer relationships, generating sales orders, and providing exceptional customer service to our dealers and retail customers.Key...

  • Vice President of Total Rewards

    2 months ago

    Malvern, Arkansas, United States Siemens Medical Solutions USA, Inc. Full time

    Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your...

  • Senior Compliance Director, Financial Crimes Program Manager

    5 days ago

    Malvern, Arkansas, United States Vanguard Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Compliance Director to lead our Financial Crimes program. As a key member of our global team, you will be responsible for managing enterprise-wide financial crimes governance, risk, and strategy, as well as technology oversight.Key ResponsibilitiesFinancial Crimes Governance and Risk...

  • Shift Leader

    3 weeks ago

    Malvern, Arkansas, United States Dunkin, Baskin Robbins Full time

    Join Our Team at Dunkin' Donuts FranchiseeAs you consider working with us, it's important to know that you are applying to be part of the Dunkin' Donuts franchise team, not Dunkin' Brands, Inc., Dunkin' Donuts, or any of their related companies. Your information will be shared exclusively with the franchisee. If you become part of our team, the franchisee...

  • Compliance Expert, Financial Crimes Operations

    5 days ago

    Malvern, Arkansas, United States Vanguard Full time

    Job SummaryVanguard is seeking a highly experienced Senior Compliance Director to lead our Financial Crimes program. As a key member of our global team, you will be responsible for managing enterprise-wide financial crimes governance, risk, and strategy. This role requires a strong subject matter expert with a proven track record in AML compliance, risk...

  • Regional Administrative Coordinator

    1 week ago

    Malvern, Arkansas, United States The Sherwin-Williams Company Full time

    Position OverviewThis role is crucial in delivering comprehensive administrative assistance to the Area, specifically to the Area Vice President of Sales. Responsibilities are diverse and encompass:Communication Management: Overseeing correspondence and organizing meetings.Data Management: Inputting and maintaining information within the Human Resources...

  • Senior Manager, Fraud Analytics and Risk Mitigation

    1 week ago

    Malvern, Arkansas, United States Vanguard Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Manager to lead our Fraud Analytics and Risk Mitigation efforts. As a key member of our team, you will be responsible for developing and implementing strategies to prevent and mitigate fraud across the enterprise.Key ResponsibilitiesLead Fraud Analytics and Risk Mitigation: Develop and...

  • Federal Account Executive

    1 week ago

    Malvern, Arkansas, United States Siemens Medical Solutions USA, Inc. Full time

    Join Siemens Medical Solutions USA, Inc. in our mission to enhance healthcare accessibility and combat significant health challenges worldwide.About Us: At Siemens Medical Solutions, we are at the forefront of healthcare innovation, striving to deliver breakthroughs that make a difference in patients' lives globally.Our Team: We are a diverse group of over...

  • Healthcare Equipment Service Specialist

    2 weeks ago

    Malvern, Arkansas, United States Siemens Medical Solutions USA, Inc. Full time

    Are you ready to contribute to the advancement of healthcare technology and improve patient care? At Siemens Medical Solutions USA, Inc., we are at the forefront of healthcare innovation, delivering exceptional solutions for medical imaging and diagnostics. Position Overview: We are seeking a dedicated Customer Service Engineer (Union) to join our team. This...

  • Risk Management Director

    1 week ago

    Malvern, Arkansas, United States Balfour Beatty Campus Solutions Full time

    About the RoleThe Risk Management Director will play a critical role in guiding the business and ensuring its compliance with Balfour Beatty Campus Solutions' Enterprise Risk Management (ERM) Framework and application of the Group Risk Management Process at business, functional, regulatory, and operational levels.Key ResponsibilitiesDevelops a process for...