About Our Client Our client is a leading pharmaceutical company dedicated to transforming the landscape of oncology care. With a relentless focus on innovation and patient-centric solutions, we are committed to making a meaningful difference in the lives of cancer patients worldwide. As our client continues to advance its oncology portfolio, they are seeking a strategic and experienced Senior Brand Manager to lead the marketing efforts for the flagship oncology product.
Job Description Prepare and submit regulatory submissions, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), marketing authorisation applications (MAAs), and variations, ensuring compliance with regulatory requirements and time lines. Liaise with regulatory authorities, including the FDA, EMA, and other global health authorities, to facilitate the review and approval of regulatory submissions and address inquiries or requests for additional information. Provide regulatory guidance and support to cross-functional teams, including Research & Development, Quality Assurance, Clinical Development, and Manufacturing, to ensure alignment with regulatory requirements throughout the product life cycle. Monitor and interpret changes in regulatory requirements, guidelines, and standards, and communicate implications to relevant stakeholders to ensure compliance and mitigate risks. Participate in regulatory strategy development, including product development plans, regulatory pathways, and submission strategies, to optimise regulatory outcomes and minimise time to market. Maintain regulatory documentation and records in accordance with internal procedures and regulatory requirements, ensuring accuracy, completeness, and accessibility for regulatory inspections and audits. Support regulatory compliance activities, including regulatory intelligence, regulatory assessments, and regulatory agency inspections, to maintain compliance with applicable regulations and standards. The Successful Applicant Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or related field; advanced degree (e.g., Master's or PhD) preferred. 4 years of experience in regulatory affairs roles within the pharmaceutical industry, with a strong understanding of regulatory requirements and processes. Knowledge of FDA regulations and guidelines, as well as international regulatory requirements. Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. Strong attention to detail and analytic skills, with the ability to interpret and apply complex regulations and guidelines. Highly organised with the ability to manage multiple projects and priorities in a fast-paced environment. Experience with regulatory submissions and interactions with regulatory authorities is preferred. What's on Offer Competitive salary and benefits package. Opportunities for professional development and advancement. Collaborative and inclusive work environment. Meaningful work contributing to the development and commercialisation of life-saving medicines.
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