2025 University Recruiting- Global Regulatory Affairs-CMC Co-Op

Job Description

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Animal Health Division can provide you with great development and a chance to see if we are the right company for your long-term goals

Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. GRA CMC PMs are also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.

The Co-op will assist Product Managers (PM) in their role by taking on assigned projects that are part of the PMs’ daily activities while further developing their technical, organizational and communication skills interacting with cross-functional project teams.

Examples of projects and assignment areas include:

• Assist with the system transition to Regulatory Information Management Systems (RIMS) SharePoint and s: drive to Archives and Alexx

• Fulfill document requests received via GRA Request Tracking Tool (RTT) to support PMs to focus on submission writing by liaising with cross-functional stakeholders

• Renewals & Geo-Expansions– GMP licenses, certificates, reports, etc.

• Backlog reduction; Metrics support

• Health Authority List of Questions (LoQs) trending

• Collect and organize LoQs

• Analyze and trend; develop metrics

• Regulatory Affairs Detailed Application Verification (DAV)- verification, maintenance

• Assist with other activities, e.g. new colleague onboarding/training scheduling

• Optimize existing processes/ analyze for improvement opportunities

Required Education and Experience:

• Must be currently enrolled in a sophomore or junior level curriculum working toward a Bachelor’s degree, or pursuing a Master’s or higher degree in related sciences (engineering, biological sciences or chemistry) or regulatory affairs discipline

• Have superior analytical and technical competency as demonstrated by excellent academic record and work achievements.

• Have strong communication skills, personal character, and ethics

• Have working knowledge MS Office suite

Preferred Experience and Skills:

• Knowledge of Six Sigma principles

• Have leadership accomplishments achieved through direct leadership roles or leading by influence.

• Have demonstrated delivery results in a multi-functional, multi-disciplinary environment.

• Candidates should have a minimum GPA of 3.0

Under New York City, 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:

$39,600.00-$105,500.00

FTP2025

MAH2025

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, 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”.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• 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:R312981