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Senior Regulatory Affairs Specialist

2 months ago

Trenton, United States MSD Malaysia Full time

Senior Regulatory Affairs Specialist

Job Description: Execute the Regulatory Road Map of the products in the Assigned Portfolio. Ensure compliance with local regulations to achieve the regulatory objectives for the subsidiary. Provide advisory and support to HQ stakeholders, marketing, logistics, quality, planning divisions, among others, in the projects that are required. Interact with the agency, follow up on regulatory filings and procedures related with the portfolio and projects assigned as required. Main functions: Be updated on new or changes in laws, regulations, normative, in force or under proposal to keep the company aware and in compliance with the different government regulations. Ensure and execute regulatory strategy and compliance for preparation, submission and monitoring of the regulatory procedures such as: New Registrations (OMA), New indications, Renewals, Variations, and other regulatory procedures in general, etc. Support Tenders and Sales (and other areas that may require it) obtaining the necessary documentation for their processes (eg: Letters, GPM, Certifications, among others) Establish good working relationships with both internal and external staff (regulatory agency, associations, regulatory consultants) maintaining a professional image on behalf of the company. Execute labeling updates (information to prescribe and insert) of the products within the established due dates. Planning filing and implementation in compliance with what is approved or required by HQ and the regulatory agency. Protect the company's information by ensuring that it is not disclosed except when necessary and when it is duly covered with the appropriate confidentiality agreements. Execute Regulatory Road Map for portfolio assigned. Provide revision to local RA SOPs updates and comply with the established there. Maintain updated the certificates of Good Manufacturing Practices of all the corresponding sites and Certificates of Pharmaceutical Products for portfolio assigned. Perform trainings as required within the established times. Perform champion/SME tasks of the assigned process or internal system. Keep updated the different corporate regulatory tracking, repository, or archive tools, etc. within the established times, maintaining KPIs with required standard. Request artworks updates when apply through the corporate system, ensuring right first time within the established times. If required, could be responsible of people management responsibility, trainee or contractors. Participation and/or collaborative in trade associations. Qualifications: Bachelor’s degree in Pharmacist / Pharmaceutical sciences required. Masters or PhD related with pharma o business (MBA, projects, marketing) preferred. Fluent English - speaking, writing, reading- required. Experience : More than 5 years in pharmaceutical industries in Regulatory affairs positions. Prove deep knowledge in local regulations general and specific for drugs, small molecules, and biologics. With Regulatory experience registering small molecules and biological products. Management internal platforms/programs for regulatory activities. Skills : Demonstrate ethics and integrity. Focus on the patient. Competitive decision making. Operational and commercial management. Financial and business broad vision. Effective communication. Effective execution capacity. Sense of urgency, initiative. Strategic thinking. Develop Talent. Regulations and management compliance. Data analysis.

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