Merck Executive Director, Regulatory CMC, Medical Device and Combination Product Lead #NCP1 in Lansdale, Pennsylvania
Reporting to the Head of Regulatory CMC, the Executive Director Regulatory CMC, Medical Device and Combination Product (MDCP) Lead is responsible for directing and overseeing the development and execution of CMC regulatory strategies supporting the MDCP elements of the Organon portfolio. This role will serve as the single point of contact to senior leaders for making regulatory CMC decisions that ensure the high quality of regulatory submissions for the medical devices and combination product aspects of combination products (pharmaceutical and biologics with medical device elements). This lead plays a critical role in driving alignment across CMC and partner organizations in Manufacturing, Research and Development, Business Development and Commercial to identify and communicate global MDCP regulatory requirements, risks and mitigations to ensure products remain compliant with evolving regulatory expectations.
Critical to this role is the ability to effectively recruit and develop talent to grow the MDCP CMC capability within Organon. This also includes developing programs to educate and increase expertise across Regulatory CMC teams on combination products, challenges and opportunities. The CMC MDCP Lead will collaborate with the CMC Women’s Health and Diversified Brands Franchise Leads and Regulatory CMC Product Leads to support the pre and post approval combination products CMC strategy across all the modalities (pharmaceuticals and biopharmaceuticals).
Guide a team responsible for providing scientific and regulatory guidance on MDCP requirements to Regulatory CMC experts during development and for marketed products and assures that the information available will meet regulatory expectations for intended countries.
Identifies, communicates and achieves stakeholder alignment on innovative and scientifically sound approaches to gain approval and clearance of medical devices and associated products; demonstrates the ability to develop creative and imaginative approaches to significantly complex problems and proactively mitigate potential regulatory challenges.
Implement the framework for assuring robust regulatory strategies, risk assessments and regulatory review processes for combination products are developed and updated as CMC requirements for combination product rapidly evolve.
Performs risk assessments for strategic decisions to address significant issues by applying an appropriate level of risk, defining the probability of success and recommending mitigation approach. Communicates recommendations to stakeholders to obtain alignment.
Monitors the global regulatory environment to identify changes to MDCP CMC regulations and works closely with the Head of Regulatory CMC to implement any required updates to CMC strategic approaches, processes and procedures to meet evolving regulatory expectations. Continuously adapts according to company strategies to build MDCP expertise around devices, digital health, and future business development opportunities.
Leads the development and implementation of business processes and initiatives associated with the CMC aspects of medical devices and combination products to enable compliance with regulations.
Develops and maintains expert knowledge of current and evolving global regulatory CMC requirements for medical devices and combination products for initial clearance, registration, re-registration and post-approval changes.
Collaborate with global stakeholders and peers, to align on priorities and support the achievement of product/portfolio goals which may also include organizational initiatives, on an as needed basis; ability to flexibly respond to changing priorities or unexpected events.
Direct communications with regulatory agencies regarding MDCP issues to facilitate review and approval of submissions.
Anticipate potential challenges impacting the business and proactively influence and recommend approaches to minimize regulatory risk within the company and the external regulatory environment.
Represents CMC on key executive level committees and meetings. Establishes strong cross-functional and divisional relationships with key stakeholders, customers and external organizations.
Demonstrated ability to recruit, train, develop and motivate staff to achieve a high performing Team and drive continuous improvement.
Maintains a high level of professionalism, integrity, efficiency, and follow-through as the leader of their teams and embodies the core corporate values; possesses excellent interpersonal and listening skills, ability to work collaboratively in a team structure and to work well under pressure.
- Degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, Pharmacy
Minimum of fifteen (15) years of pharmaceutical industry experience; ten (10) years with an advanced degree.
Minimum of seven (7) years working in Regulatory CMC, with progressive experience in leading global programs across the product life cycle
Minimum of five (5) years managing people
The ideal candidate will have strong experience in Regulatory CMC with strong leadership skills, as well as demonstrated understanding of medical device and combination product technical aspects and regulatory requirements.
The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
He/she must have a depth of experience in defining global MDCP CMC strategies, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.
The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.
The candidate must have demonstrated experience in building, rewarding and retaining key talent. He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
The candidate must be proficient in English; additional language skills are a plus
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Requisition ID: R59608
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