Address
Form of workJob Description
The Senior Specialist US Regulatory Affairs position is accountable for maintaining the pesticide registrations and/or providing FDA submission support for labeling and chemistry, manufacturing, and controls (CMC) submissions and works as part of a Team to prepare and submit marketed product reports to the regulatory authorities; maintains US state registrations, labeling, drug listings; the registration database; and the veterinary compendium; reviews and submits advertising and promotional labeling; obtains US Free Sales Certificates; submits three-day alerts and recall submissions.
You may lead and support teams on various regulatory topics, optimize procedures, processes, infrastructure, assist with document management and offsite archiving as necessary, provide regular updates to management and escalates issues and you will report to the Executive Director of US Regulatory Affairs.
Key Functions
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
EPA Portfolio Management: Maintain the registered US pesticide products throughout their lifecycle which includes supporting label changes and extensions, reviewing advertising and promotional labeling and preparing notifications, amendments or other submissions as required by EPA
FDA Submission Support: Submit post-approval CMC and Labeling submissions to FDA and assist with the archiving of the submissions, receive and direct communications from FDA related to CMC and Labeling submissions and assist the Director with US 3-day alerts and Recall submissions
Obtain documents from source areas for inclusion in marketed product reports (e.g., periodic Drug Experience Reports, Quarterly Sales Reports and Antimicrobial Reports), prepare reports for submission (eSubmitter) to regulatory authorities
Maintain, monitor and approve current versions and revisions related to all pharmaceutical and pesticide labeling for US marketed products
Coordinate with the Director/Associate Directors, the review and submission of advertising and promotional labeling
Maintain and update state registrations for all assigned marketed products
Build strong knowledge of federal and state regulations and guidance, as applicable and effectively convey information within the company
Maintain US drug listings, the registration database and the veterinary compendium
Obtain Free Sales Certificates
Lead or participate on teams related to regulatory topics and optimize processes, procedures and infrastructure
Back-up Coordinator for offsite archiving of study documents and communicating when documents are received by or shipped to external sites
Provides regular updates to management and escalates issues.
Other tasks or projects assigned
Education Required
Bachelor degree in a relevant discipline such as animal science, veterinary technology, immunology, toxicology/pharmacology, chemistry, biology, business, or regulatory with five years regulatory experience in the pharmaceutical industry,
Master degree in a relevant discipline with three years regulatory experience
NOTICEFORINTERNALAPPLICANTS
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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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
EEOC GINA Supplement
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:
$97,680.00 - $153,700.00Available 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequisition ID:R268402
