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Director, Global Regulatory Lead (GRL), Global Regulatory Affairs Strategy, Neurology & Immunology

Company: Millipore Corporation
Location: Billerica
Posted on: January 12, 2022

Job Description:

A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. -Your RoleIn the Global Regulatory Affairs group, you will be actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation.As the Director you will -function as a Global Regulatory Lead responsible for preparation and execution of regional regulatory activities and submissions, and to develop and lead global regulatory strategies, lead submission and approval of clinical trials, original marketing applications and post-approval applications or other related regulatory submissions (orphan designation, annual report, pediatric plans and DSUR etc.)

  • Lead the development and evaluation of regulatory strategies for projects
  • Chair and lead the Global Regulatory Strategy Team (GRST), the team of cross-functional regulatory experts (i.e. regional leads; project management; CMC; labeling) responsible for the integrated global regulatory strategy for assigned assets and programs
  • Serve as a core member of the Global Product Team (GPT) for as the voice and face of the regulatory organization in support of the integrated development strategy for the assigned assets / programs
  • Leading Health Authority communications including preparation of all regulatory documents at different regulatory milestones; -and leading meeting activities including rehearsals
  • Lead the preparation, submission and approval of regulatory documents (e.g., clinical trial applications, orphan drug designation, Pediatric plans, authority meeting packages) and marketing authorization applications globally or regionally
  • Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications.
  • Contribute to due diligence evaluations in support of business development opportunities in the therapeutic area of interest
  • May also serve as regional lead in addition to being global lead
  • May have direct reports Who You AreRequired:
    • Bachelors degree, higher degree preferable (Pharm.D., MSc, PhD, MBA)
    • Minimum of 10 years' industry experience and 8 years' relevant regulatory experience
    • Global experience in preparation and management of comprehensive drug development programs (IND/CTA submissions for FIM to phase 3 and registration phase)
    • Prior experience with global Health Agency interactions.
    • Development and preparation of successful regulatory strategies with ability present and defend such strategies in both verbal and written communication
    • Experience with regulatory project development activities and MAA/NDA/BLA management.
    • Knowledge of international regulatory affairsPreferred:
      • Experience as leading teams within a matrixed organization.
      • Experience with both small molecules and biologics is an advantage
      • Ability to think strategically
      • Excellent written and spoken communication skills
      • Good interpersonal skills
      • Attention to detail
      • Ability to work in teams
      • Strong organizational and planning skillsWhat we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!Curious? Apply and find more information at -The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. -This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Keywords: Millipore Corporation, Billerica , Director, Global Regulatory Lead (GRL), Global Regulatory Affairs Strategy, Neurology & Immunology, Executive , Billerica, Massachusetts

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