Associate Director, Regulatory Liaison - Vaccine & Infectious Disease
The Regulatory Affairs Headquarters Associate Principal Scientist supports products in the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work closely with a global liaison(s) to help develop and implement a global strategy for registration and/or maintenance of VID products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance or competitive intelligence.
Primary activities include, but are not limited to:
Assists in regulatory agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.
Implements strategy to develop agency background packages and documents associated with regulatory submissions for marketing applications.
Communicates with agencies and attending agency meetings to assist the Global Liaison.
Participates as an active member on the Global Regulatory Team. They will attend cross-functional meetings as required, in collaboration with, and to assist the global liaison.
Conducts research and review of guidelines, regulatory precedence and competitive Intelligence to facilitate development of regulatory strategy. Assists the global liaison in authoring of regulatory strategy documents.
Collaborates and communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., Clinical Research, Safety Assessment).
Supports maintenance (e.g., quality compliance and life cycle management) of VID programs.
Supports of Global Liaison in label development.
Assists with process improvement initiatives.
Performs regulatory administrative activities as needed.
Education Minimum Requirements:
M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline. Other degrees such as master's or bachelor’s with experience to suggest equivalent ability to function in this position.
Required Experience and Skills:
M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline, or master’s degree with at least 3 years of relevant experience in pharmaceutical industry, or
Bachelor’s degree with at least 6 years of relevant experience in the pharmaceutical industry
Excellent communication skills (both oral and written).
Good organizational skills with a proven ability to simultaneously balance diverse activities or multiple projects.
Strong scientific and analytical skills with attention to detail.
Preferred Experience and Skills:
Prior regulatory experience.
Experience in drug development, particularly anti-infectives and/or vaccine products is highly preferred.
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.
NOTICE FOR INTERNAL APPLICANTS
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.
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.
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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Expected salary range:$130,960.00 - $206,200.00
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