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Expert Regulatory Affairs

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Job Description - Expert Regulatory Affairs

Regulatory Strategy and Planning: Develop and implement regulatory strategies for the re-registration of pharmaceutical products with authorities. Coordinate with cross-functional teams to ensure alignment on regulatory timelines and deliverables. Documentation and Submission: Prepare and compile high-quality regulatory submission dossiers in accordance with regulatory requirements. Ensure all documentation is accurate, complete, and submitted within the required timelines. Monitor regulatory changes and updates to ensure compliance with all relevant guidelines and regulations. Maintain up-to-date knowledge of regulatory requirements and ensure that the company complies with all applicable laws and standards. Communication and Liaison: Act as the primary point of contact with authority/consultant, and other relevant regulatory authorities. Facilitate communication between internal departments and external stakeholders to ensure a smooth approval process. Project Management: Track and manage the progress of all re-registration activities. Provide regular updates to senior management and other stakeholders on the status of approvals. You Bring: Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred. Minimum of 7-10 years of experience in regulatory affairs within the pharmaceutical industry. Proven track record of successful regulatory submissions and approvals Strong understanding of country guidelines and regulatory requirements. Experience with legal entity changes and their impact on regulatory approvals. Familiarity with electronic submission systems and regulatory databases. The application process. Interested in this position? Please apply on-line by uploading your resume in English via our career portal. For further information, please contact Avinash Pandey, Talent Acquisition Manager ([email protected]) Equal Opportunities Commitment We aim to build a workplace where opportunity really is equal, so everyone can thrive. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law. We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.
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