Regulatory Affairs Intern

Job description

Job Description

The Pharmacy Internship Training Programme will be conducted under the supervision of the Regulatory Affairs Team for graduates of local accredited Bachelor of Pharmacy ("BPharm") Programs offered by The University of Hong Kong ("HKU") and The Chinese University of Hong Kong ("CUHK"). The Pharmacy Internship Training Programme covers various aspects across different departments, including:

• Regulatory Affairs
• To handle New Product Registration and product Registration Life-Cycle Management, with strategic planning for new launch and/or implementation of post-approval variation; Provide support to cross-functional teams such as Tender and In-Market Quality support.
• Medical Affairs
• To handle inquiry & patient program, experience to visit with HCP & symposium.
• Pharmacovigilance
• To handle AE reporting & if there is a need, to verify the data.
• Others
• Attending Drug Office seminar and/or Medical Device seminar, opportunities to work with different stakeholders, e.g. DOH officers, CPO, Legal Advisor etc.

Required Skills

Adverse Event Report, Audits Compliance, Collaborative Development, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Pharmacovigilance, Policy Implementation, Product Registrations, Records Retention Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Strategy Development, Stakeholder Engagement, Strategic Management, Strategic Planning 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: 10/30/2026 *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.