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Regulatory Affairs Manager

2 months ago

Trenton, United States MSD Malaysia Full time

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Regulatory Affairs Manager

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remote type

Hybrid

locations

TWN - Taipei - Taipei City

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

R300858

Job Description Summary of Position Lead Regulatory Affairs team of our company's Animal Health Taiwan and Hong Kong to be responsible for all products (e.g. but not limited to, biological, pharmaceutical and devices) registration and market authorizations maintenance to be compliance to the related regulations. Strong relations with the various administrative authorities and stakeholders within the framework of the company's development strategy and in line with veterinary biological, pharmaceutical and devices regulations. Manage PV, internal compliance, and policies to ensure business operation is compliant with the company’s policies. Major Activities and Responsibilities Product Registration: Lead the RA team to prepare and manage the annual product submission and approval plan by executing the corresponding work tasks force for existing market authorizations and upcoming new registrations. Involve in the country’s registration pipelines and strategically take all necessary actions or alternatives to accelerate the registration approval. Well communicate with company’s RA team (GRA) to ensure the product dossiers meet the local regulatory requirements. Maintain strong and good relationship and network with the different departments of authorities. Local Regulation Monitoring & Compliance: Lead the RA team to provide updates on legislation and regulations changes of Taiwan animal health/ veterinary products registration, importation, local quality inspection, testing. Timely communicate with GRA (regional, plant site and global) on changes in local requirements and propose solutions in compliance to new local regulations to ensure product supply. Engage with local or regional animal health associations and stakeholders to raise concerns and propose a compromised solution with authorities to minimize the regulatory hurdles for animal health industry. Ensure business operation is aligned with the relevant regulations. Building Relationship with Official Bodies: Identify and approach key officers of official entities, laboratories, institutions and universities which involved in registration, technical verification, importation, inspection and testing. Demonstrate good image and branding of our company's AH Taiwan in connection with the aforementioned entities with high level of data input, knowledge, expertise exchanges and experience sharing. Building networking and relationship with the key opinion leaders, experts, stakeholders and authorities to portray our company'sAH’s professionalism and reputation. Participate in competent professional bodies and contribute relevant resource whenever is relevant for registration of future pipelines. Manage internal PV, policies, and compliances. Lead the RA team to ensure the PV management in line with the requirement of our company's AH. Ensure business operation is compliant with our company's AH’s policies and compliance requirement. Background Requirements Prefer bachelor diploma in science or veterinary medicine. At least 10 years’ experience in regulatory affairs in animal health industry. Have major experience in both of biological and pharmaceutical products of animal health. Fluent in Mandarin and English. Based in Taipei office. Hybrid work with 30% of travelling Required Capabilities (Skills, Competencies) Solid knowledge of Taiwan regulatory processes and requirements. Good communication and negotiation skill. Strategic thinking and planning with agility. Strong business sense. Project management and problem-solving. People management Focused and strong network building 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: Regular

Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid

Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 07/17/2024

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