Intern- Regulatory Affairs- CMC

Job description

Job Description Our company starts your journey on the career path within the pharmaceutical industry. Not only will you learn skills both technical and professional but work on projects that will contribute towards enhancing people’s lives across the world. You will be part of a diverse and inclusive, and multi-skilled team of highly motivated individuals. We keep patients at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. So, what will you be responsible for? The Intern will be involved in and responsible for the execution and management of the APAC region submissions including new product registrations and life-cycle submissions to keep our products compliant and available for patients. In this role you will be working to: • Generate regulatory strategies • Liaise with colleagues globally • Review submission packages Additionally, you will: • Work alongside our team to deliver on operational excellence projects • Work alongside our team in developing best practises for regulatory science • Learn and apply regulatory policy and advocacy • Provide ad-hoc support as needed This internship will be completed in a hybrid model (virtual and/or on-site). You will be looking to complete a 6-month placement in your third or penultimate year of study, returning to your course at the end of the placement. The ideal person will have: • A minimum of Diploma or BSc in a scientific discipline such as chemistry, biological sciences, engineering, or a related field. Fields of study include (but are not limited to) Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry (or equivalent qualification) • Fluency in an additional language commonly used in the APAC region is a plus • Demonstrated analytical skills and detail-oriented Proprietary Qualities we look for… Someone who: • Communicates, participates and collaborates as one team; winning and losing together • Focuses on what matters the most to create the greatest value for patients • Acts with urgency, rigor and determination to enable us to continue to deliver our medicines and vaccines around the world • Is intellectually curious, adapts and has a commitment to never give up, whether we succeed or fail • Aligns with and fosters a culture of diversity and inclusion; being part of an inclusive environment where everyone is able to contribute their best ideas • Encourages curiosity, voices their opinions and engages in healthy debate to improve ideas and decisions to achieve better outcomes *This role is for the January 2027 intake Required Skills: Analytical Problem Solving, Analytical Problem Solving, Analytical Thinking, Analytical Tools, Audits Compliance, Biology, Chemical Engineering, Compliance Investigations, Critical Thinking, Data Quality Assurance, Decision Making, Detail-Oriented, Documentation Standards, Document Control Systems, Electronic Common Technical Document (eCTD), Liaison Work, Multidisciplinary Teamwork, Policy Implementation, Proactive Thinking, Records Retention Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Documents, Regulatory Management {+ 6 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply 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: Intern/Co-op (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/30/2026 *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.