Job Description

　　Our Regulatory Affairs CMC team is key to expanding access to our existing vaccines products and bringing new vaccines to the world.

　　Reporting to the Assoc. Vice President, the Executive Director is responsible for developing and implementing CMC regulatory strategies for our vaccine programs in accordance with global regulations and guidance documents as well as managing a team of CMC scientists in the preparation and submission of CMC dossiers and updates to product registrations. The role will require partnership with external and internal partners and occasional travel.

　　Accountable for the delivery of all regulatory milestones for families of moderate to higher complexity products through the product lifecycle, including assessment of the probability of regulatory success together with risk mitigation measures. Monitor changes in the external environment and anticipate impact on regulatory strategies. Generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. Critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data; convey complex issues in a succinct and logical manner.

　　Lead a team of 10+ regulatory scientists and people managers in support of six vaccines and biological therapeutics registered worldwide and various vaccines in clinical development.

　　Primary responsibilities include, but are not limited to:

　　• The executive director is accountable for the delivery of all regulatory milestones for assigned higher complexity products through the product lifecycle, including assessment of the probability of regulatory success together with risk mitigation measures.

　　• Guide the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for projects of increasing complexity.

　　• Lead meetings with global health authorities on the CMC aspects of product development and registration through post-approval life-cycle management.

　　• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.

　　• Manage execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.

　　• Demonstrate a solid knowledge of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and continued market supply of our vaccine products worldwide.

　　• Conduct all activities with an unwavering focus on compliance.

　　Technical Skills:

　　• 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 convey 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.

　　• The candidate must be proficient in English; additional language skills are a plus.

　　Leadership Skills:

　　• Demonstrated ability to work across departments to test and advance innovative processes, hypotheses, and methodologies; encourages curiosity and challenges the status quo in order to foster innovation.

　　• Exercises foresight and judgment in planning, organizing, and guiding complex projects. Track record of successfully applying high-level judgment in a variety of complex and unprecedented situations.

　　• Demonstrated effective leadership, written and verbal communication, and negotiating skills.

　　Relocation assistance: Yes for US, No for International

　　Education:

　　BS/BA in a biological science, engineering, or a related field required. Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.

　　Experience:

　　o Minimum fifteen (15) years of relevant industry experience (10 years with an advanced degree), including biological/vaccine research; manufacturing, testing, or licensure of biological/vaccine products; or related fields.

　　o Minimum ten (10) years of Regulatory CMC experience working with biologics or vaccines.

　　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.

　　Current Employees apply HERE

　　Current Contingent Workers apply HERE

　　US and Puerto Rico Residents Only:

　　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.

　　We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

　　EEOC Know Your Rights

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　　Pay Transparency Nondiscrimination

　　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.

　　Learn more about your rights, including under California, Colorado and other US State Acts

　　U.S. Hybrid Work Model

　　Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

　　Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

　　Expected salary range:

　　$235,280.00 - $370,400.00

　　Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

　　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.

　　Employee Status:

　　Regular

　　Relocation:

　　VISA Sponsorship:

　　Travel Requirements:

　　Flexible Work Arrangements:

　　Shift:

　　Valid Driving License:

　　Hazardous Material(s):

　　Requisition ID:R270581