Job Description

The regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations. This role will establish project plans, monitor progress, coordinate resources, and ensure timely completion of project deliverables. Will also be responsible for supporting all aspects of the submission process for regulatory documents to health authorities. This includes assisting with the planning, preparation, publishing, and tracking of regulatory submissions such as new drug applications, marketing authorization applications, amendments, supplements/variations, renewals, and annual reports.

The role also ensures the efficient management of regulatory documentation and information to meet internal and external requirements, maintain regulatory systems and technologies to support the operational needs of the regulatory affairs department. The incumbent will be knowledgeable and work in accordance to applicable regulatory requirements, guidelines, and industry standards as well as update regulatory changes and communicate relevant updates to the regulatory affairs team as necessary. Implement and maintain processes to ensure compliance with electronic submission formats and global regulatory standards, and identifies opportunities to enhance efficiency and streamline regulatory operations processes.

Also take lead or help lead process improvement initiatives, evaluate existing workflows, and implement best practices to improve the quality, accuracy, and speed of regulatory operations activities. Perform regulatory tasks in Veeva system (Alexx Submissions, Registrations and Archive), and any other activities, as requested by management.

Minimum education required:

• Bachelor's or Master's degree in a relevant scientific field or regulatory affairs.

Required experience and skills:

• Three (3) years of experience in managing regulatory submissions and document management systems such as Veeva Vault and RIMS

• Strong knowledge of regulatory requirements, guidelines, and industry standards related to regulatory operations.

• Experience in managing regulatory submissions and document management systems.

• Familiarity with electronic submission formats and tools (such as esubmitter and CTD).

• Knowledge of regulatory systems and technologies (such as Veeva Vault and RIMS).

• Excellent organizational and time management skills.

• Strong analytical and problem-solving abilities.

• Effective communication and interpersonal skills.

• Leadership experience and the ability to manage and develop a team preferred.

• Project management certifications (e.g., PMP, PRINCE2) preferred.

• Experience as a project manager preferred.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$104,200.00 - $163,900.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

03/17/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R339641