We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Reporting to the Head of Global Regulatory Affairs and Clinical Safety (GRACS ) Vaccines the Associate Vice President (AVP) will provide regulatory leadership, oversight and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for a Vaccines Franchise. This includes preparation of applicable sections of clinical applications (IND and IMPD), Agency Background Packages, Worldwide Marketing Applications, Post-approval Applications and responses to Agency questions for global markets.
The individual leading this team, will need to demonstrate an ability to navigate the complexity, while keeping the team motivated, engaged and providing them opportunities to develop and grown in their roles/careers. He/she will lead a team of approximately 25-30 permanent employees and numerous other contractors to deliver on priorities. He/she will lead a team of individuals that will comprise of Distinguished Scientists/Senior Directors/Directors and below.
The primary focus of the position is providing direction to team leaders and members that are responsible for developing and executing regulatory strategies and making decisions that ensure the high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during various phases of development and network expansion, defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence and incorporating knowledge of the changing regulatory environment. This individual will be a key, senior member of the Vaccines CMC leadership team supporting the department in all relevant areas of expertise.
Duties and responsibilities include, but are not limited to the following:
Oversee the continued rapid growth of the CMC team supporting this Franchise.
Hire, mentor and coach the team members and leaders in support of the various expansion programs.
Responsible for the development and maintenance of an overarching strategy relating to the global approval of vaccine and its maintenance in various markets.
From a regulatory CMC perspective, this individual will be accountable for all CMC regulatory topics related to Franchise.
He/she will work closely with clients, customers/or executives to assure that the optimal regulatory path is used to facilitate supply chain optimization and expand manufacturing facilities. This will include the evaluation of innovative approaches, including tools such as PACMP's (post approval change management protocols) to execute changes in an optimal manner.
He/she will utilize (while continuing to also develop) his/her external network, that includes regulators to understand the trends
He/she will adopt innovative approaches and enable innovation in emerging markets by enabling dual sourcing and other approaches to simplify the regulatory landscape.
The incumbent will utilize extensive knowledge of the global regulatory landscape to influence stakeholders and customers, thereby prosecuting changes that are value added (reducing non-value added work), fortifying the supply chain by facilitating risk reduction measures (duality) and enabling change in some markets by influencing the regulatory environment. Enabling these in an organized and thoughtful manner by influencing stakeholders enables the optimization of the supply chain while risk proofing it, thereby assuring availability of product to the patients.
In addition to the above he/she will be in charge of a franchise that is unique with exceptional growth, resulting in complexity that is unique and unprecedented. This complexity includes:
Managing changes to optimize the manufacturing process, control strategy etc. and increasing the robustness, in parallel to expanding the supply chain.
Complex process changes needed to robust the API process that need to be registered globally for multiple DS sites.
Addressing one-dose programs utilizing novel adjuvants including LNP's.
Influencing health authorities such as CDE to accept duality of drug substance and other nodes to derisk potential failure modes and assure supply
Utilize novel concepts such as PACMP's and qualification protocols to facilitate change management.
This individual will oversee all Franchise program elements including:
Manage and develop the team leads and members assuring that the teams provide expert regulatory support to each program
Work closely with stakeholders to develop processes and clarify roles and responsibilities to assure timely strategy and dossier development
Assure the development and maintenance of IND and BLA templates and TOC's suitable for efficient use by the authoring community Develop programs to educate and increase expertise across the team
Collaborate with the VID Regulatory Franchise Leads in providing appropriate strategy and governance for the integrated global regulatory teams
Assure that the teams utilize all elements and resources of the CMC operating model to support timely, well-coordinated submissions and approvals of the original application and post approval submissions worldwide
Accountable for 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 & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges.
Drive application of regulatory strategies and concepts across multiple disciplines and multiple organizations, including working directly with Senior Leadership in our Manufacturing Division and our Research & Development Division in these areas.
Embody the Company's Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently.
Continuously evaluate and develop talent within the team and prepare a succession plan.
Use recognition and rewards to promote team and organizational collaboration.
Set a vision for the team and hold employees accountable for execution of departmental 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.
Actively sponsor employees who lead and participate in our Company's initiatives.
Represent the department's needs and positions in senior leadership forums.
Develop and maintain expert knowledge of current global regulatory CMC requirements for investigational submissions, original registrations and post-approval changes. This includes knowledge of the regulatory guidance for monoclonal antibodies, combination products and innovative technology.
Identify and resolve technical and operational problems associated with regulatory strategy and submissions using rapid, disciplined decision making; collaborate with peers to resolve cross-functional obstacles using excellent critical thinking skills.
Look for innovative and scientifically sound approaches to gain approval.
Participate in the development of CMC business processes or organizational initiatives as needed.
Lead 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. Utilize expert knowledge and reputation to influence the content of new Industry Association Whitepapers, Health Authority guidance & regulations. Present and participate at industry meetings.
Minimum 15 years pharmaceutical industry experience; 10 years with an advanced degree.
Minimum 7 years working in Regulatory CMC, including the development stages of the product life cycle, and minimum 3 years managing people.
Strong experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance)
Experience managing a team of Regulatory CMC professionals.
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.
Must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.
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.
Must have demonstrated experience in building, rewarding and retaining key talent.
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.
Must be proficient in English; additional language skills are a plus.
Strong experience in vaccines/biologics pre/post approval expertise is highly preferred.
Who we are
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
If you need an accommodation for the application process please email us at email@example.com
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We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.
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