POSITION CAN BE LOCATED AT ANY OF THESE LOCATIONS:
Lansdale, PA Boston, MA Rahway, NJ Upper Gwynedd, PA West Point, PA
Job Description 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.
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.
The CMC Pre-approval Pharm Executive Director is accountable for ensuring high rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for all products within their assigned portfolio. The Executive Director, as a Senior member of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Organization, will also manage significant cross-modality projects as an extension of the overall GRACS CMC Leadership Team. This lead plays a critical role in driving alignment and execution globally across Regulatory CMC, GRACS, our Research & Development division, our Manufacturing division and our Human Health division to ensure these programs are compliant and available to patients in markets as needed.
Leads a team responsible for a group of several related products that include staff supporting pre-approval work and post-approval changes.
Ensures successful development and implementation of CMC regulatory strategy and plan for the assigned group of projects/products.
Effectively communicates CMC regulatory strategy, risk, mitigation and overall plan to the GRACS, Research & Development division, Manufacturing division and Human Health division management teams, product development teams, and executive management, as relevant.
Establishes strong cross-functional and divisional relationships with key stakeholders, customers and external organizations.
Represent GRACS CMC on key executive level meetings and leadership forums, as a delegate for the CMC Leadership Team member, as required. Actively engage as a Leadership Team member within the assigned CMC department.
Monitors changes in regulatory environment with potential strategic impact working closely with the Head of CMC Regulatory Policy.
Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues.
Ensures that all regulatory requirements are met and that systems are used appropriately to ensure proper product control. Ensures appropriate reviews, approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health Authorities.
Develops resource requirements and directs the allocation of the resources to meet profit plan. Works with the Research & Development division, the Manufacturing division and the Human Health division to prioritize work within the assigned group of products to support the profit plan.
Evaluates key business challenges of products/programs within the franchise and collaborates with team members to direct the development of new and improved solutions.
Applies appropriate combination of perspectives (business, technical, global, etc.) when making decisions and generating solutions.
Partners with the Research & Development division, the Manufacturing division and the Human Health division to ensure robust prioritization of work to meet agreed upon goals across the organization. Influences and drives development of innovative solutions to problems and ability to make rapid, disciplined decisions across divisions.
Education Minimum Requirement: Required:
Master's degree with a minimum of (15) years' experience in the Pharmaceutical Industry
Minimum of (10) years' experience in Regulatory CMC with progressive experience in leading global programs from pre-approval through post-marketing.
Minimum of (5) years People Management / Leadership experience with proven track record of developing talent.
Demonstrated ability to anticipate and influence within and across divisions/business units and in the external business and regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk
Recognized as a leader both internally and externally with broad expertise in CMC regulatory strategy and dossier management activities across product development, registration and life-cycle management. Present and influence key topics at Industry/Agency meetings and conferences.
Demonstrated ability to recruit, train and develop staff, to motivate others and drive continuous improvement.
Flexibility to operate in a matrix-managed environment and to support staff in that same environment.
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 firstname.lastname@example.org
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully 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.