Associate Vice President – Regulatory CMC Women’s Health Franchise Lead #NCP1 (m/f/d)

  • MSD International GmbH
  • Canton of Lucerne, Switzerland
  • 13/07/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

Reporting to the Head of Regulatory CMC in Organon Manufacturing, the Associate Vice President (AVP) will provide regulatory leadership and oversight to a team of Regulatory CMC Professionals in developing the global Regulatory CMC strategy and executing submissions for products within the Women’s Health Franchise. This large and growing portfolio of biologic and pharmaceutical women’s health products for contraception, fertility and beyond includes oral solid dosage forms, sterile injectable and medical device and combination products. The AVP is accountable for delivery of applicable CMC sections for life-cycle maintenance submissions, post-approval changes, Agency Background Packages, and responses to Agency questions for global markets for existing products and Worldwide Marketing Applications for new product registrations.

Core to enabling success in this role will be:

  • The ability to drive alignment with partner organizations within Manufacturing, Research and Development, Commercial, and Business Development
  • Ensuring optimal regulatory pathways are implemented to deliver on business objectives and compliant supply
  • A demonstrated ability to navigate through complexity and flexibly allocate internal and external resources to meet dynamic business priorities
  • Accountability to identify and communicate CMC regulatory risks and effectively define mitigation strategies and regulatory plans
  • Representing the CMC organization in executive forums to drive the overall strategy for the Women’s Health portfolio
  • Strength of leadership to manage a diverse, global team of approximately 30-40 staff with the sensitivity to effectively attract, recruit, and retain talent

Role Objectives

  • Proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner
  • Develop, execute & provide oversight of regulatory initiatives and strategies of significant complexity
  • Apply exceptional ingenuity to develop risk-based solutions to problems and mitigate potential regulatory challenges
  • Drive application of regulatory strategies and concepts across multiple disciplines and multiple organizations, including working directly with Executive Management across partner functions
  • Embody the Organon Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently
  • Actively coach team members to develop robust regulatory strategies, embed risk management in ways of working, and develop broad enterprise mindset
  • Continuously evaluate and develop talent within the team and prepare a succession plan
  • Set a vision for the team and hold employees accountable for execution of the organization’s policies and procedures
  • Flexibly manage and allocate resources to support execution and delivery of prioritized work to meet business commitments
  • Cultivate and foster strong collaborative relationships with stakeholders and partners across the organization
  • Advocate for the CMC organization requirements and positions in executive leadership forums
  • Monitor the global regulatory environment to identify changes with potential CMC impact
  • Work closely with the Head of CMC to implement updates to CMC strategic approaches, processes and procedures

Skills

  • Develop and maintain expert knowledge of current global regulatory CMC requirements for investigational submissions, original registrations and post-approval changes. This includes regulatory guidance for pharmaceutical, biologic and combination products and associated technologies
  • Coach team to identify and resolve technical and operational problems associated with regulatory strategy and submissions using rapid, disciplined decision making and appropriate risk tolerance
  • Collaborate with peers to resolve cross-functional obstacles using excellent critical thinking skills
  • Influence innovative and scientifically sound approaches to gain approval
  • Participate in the development of CMC business processes or organizational initiatives as needed
  • Steer the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of submissions
  • Develop and maintain an expert knowledge of Industry Association Whitepapers, Health Authority regulations & guidance documents and influence their content. Present and participate at industry meetings

Qualifications

  • Advanced Degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, Pharmacy
  • Deep and proven expertise in the pharmaceutical sector in regulatory CMC with progressive experience directing global programs across the product life cycle
  • Strong Biologics pre/post approval expertise highly preferred
  • Strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance)
  • Demonstrated ability to develop creative and imaginative approaches to problem solving and to flexibly respond to changing priorities or unexpected events
  • Depth of expertise defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision-making and critical thinking capabilities; stress resilience
  • Proven background in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data
  • Excellent communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts
  • Strength of leadership managing a team of global Regulatory CMC professionals as well as building, rewarding, and retaining key talent
  • Proficiency in English; additional languages a plus

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R59597