Merck Director Biologics, Chemistry, Manufacturing and Controls Organization Regulatory Affairs in Lansdale, Pennsylvania
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. (Position available in Boston, New Jersey or Pennsylvania).
Serve as a Regulatory Chemistry, Manufacturing and Controls Organization (CMC) team leader to provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in the pre-approval space.
This position plays a critical role in negotiating and achieving alignment in partnership with other functional areas in Global Regulatory Affairs and Clinical Safety (GRACS) and CMC development teams, manufacturing division and Health Agencies to implement new technologies in biologics manufacturing within our company.
The position is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
Manage execution of CMC documentation including Investigational New Drug/Clinical Trial Application (IND/CTA), original Biologics Licensing Agreement/Marketing Authorization Application (BLA/MAA), agency background packages and responses to health authority questions per established business processes and systems.
Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Biologics products worldwide.
Conduct all activities with an unwavering focus on compliance.
This position will manage junior team members and also coach/mentor other teams.
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, communication, interpersonal and negotiating skills.
Education Minimum Requirements
- Bachelor of Science (B.S.) in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.
Required Experience and Skills
At least fifteen (15) years of relevant experience (10) years with an advanced degree), including biological CMC development; manufacturing, testing, or licensure of biological products; or related fields.
The candidate must be proficient in English; additional language skills are a plus.
The candidate may be required to travel on a periodic basis
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.
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 .
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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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Flexible Work Arrangements:
1st - Day
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Requisition ID: R25831
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