New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.
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.
Develop and lead the evaluation and execution framework for systematically assessing regulatory policy impact in the functional areas of IQSE (Innovation, Quality & Strategy Execution). Topics will include, but not necessarily limited to the following: Electronic submission (eCTD, NeeS formats, cloud based as well as evolving structured content approaches) and their implementation, data standards (XEVMPD, IDMP, PQ/CMC) used to manage and submit data to agencies, underlying data modelling standards such as HL7v3 and HL7 FHIR, advances in global adoption of electronic labeling, Med Device / Combo Products regulations, Digital Health Solutions, and industry-changing blockchain approaches with regulatory related use-cases.
Manage and develop assigned direct reports and/or contractors as assigned
Drive an integrated IQSE (Innovation, Quality & Strategy Execution) adoption plan of policy changes and their resulting impact into company processes and system with active tracking and management through to realization across a broad range of regulation topics important to regulatory operations and submissions management.
Serve as the business process owner for Regulatory Policy Impact Assessment & Execution.
Drive identification of business requirements for development of a robust tracking system to manage the impact assessment process and to enable the oversight and tracking of compliance to regulation implementation. This will require leadership across stakeholders to define business requirements with business accountability for the delivery of this technology capability (in collaboration with Innovation & Info Mgmt and IT).
Responsible for performance management of policy execution (impact assessment + implementation) across IQSE (Innovation, Quality & Strategy Execution) functions from an effectiveness and efficiency lens to demonstrate regulatory compliance.
Coordinate the activities of IQSE (Innovation, Quality & Strategy Execution) representatives participating in external policy activities that are specific to regulatory operations and submissions management related subject matter areas to build alignment and support along with GRACS and company objectives.
Partner effectively with the Global Regulatory Policy group so that the appropriate subject matter expertise is provided for regulatory operations and submissions management related topics; provide updates on the implementation status of policy across the various topics impacting regulatory operations and submissions management.
On an as required basis, participate in meetings with country Regulatory Agencies on topical activities pertinent to the domain of regulator operations and submissions management that advance the company regulatory position in support of company policy objectives.
Graduate degree (Ph.D., PharmD, MS, MBA) in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field
RAPS RAC, PMP, or Scrum certifications
Experience Knowledge | Skills
Experience with external regulatory groups (health authority and industry groups) across regions
Deep understanding of regulatory data standards such as XEVMPD, IDMP, PQ/CMC used to manage and submit data to agencies, underlying data modelling standards such as HL7v3 and HL7 FHIR, block chain technology, e-labeling, structure content management, and/or familiarity with device standards and regulations and application to clinical trials.
Working knowledge of regulatory processes, regulatory systems and tools that enable planning, execution and analysis/reporting of regulatory submissions.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.