2025 University Recruiting- Global Regulatory Affairs-CMC Co-Op
2025 University Recruiting- Global Regulatory Affairs-CMC Co-Op
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$ 39600 - 105500
1 Vacancy
Job Description
Job Description
The Future Talent Program features Cooperative (Coop) 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 longterm 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 Coop 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 crossfunctional 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 crossfunctional stakeholders
Renewals & GeoExpansions 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 Bachelors degree or pursuing a Masters 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 multifunctional multidisciplinary 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 candidates relevant skills experience and education.
Expected salary range:
$39600.00$105500.00
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.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers 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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
Intern/Coop (Fixed Term)Relocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Preferred Skills:
Job Posting End Date:
06/2/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Exec
Employment Type
Full-Time
