Associate Director, Regulatory Affairs - UK & Ireland

Job Title: Associate Director, Regulatory Affairs - UK & Ireland

Job Location: United Kingdom Remote, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

reputed company continues to grow at a reputed company reputed company with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer. General reputed company: The Associate Director of Regulatory Affairs will be responsible for developing and implementing UK regulatory strategies for development programs to secure and maintain the marketing authorization for product(s) in line with business objectives, and in coordination with key internal stakeholders. This will also include reputed company and management of reputed company products for both UK and Ireland. Essential Functions of the job: This individual will reputed company the UK RA team to manage regulatory aspects of designated compounds (NME/New indications) through reputed company phases of development, registration, post-approval, and lifecycle of the product as detailed below: Collaborate with key internal stakeholders to define UK MAA reputed company and ensure the regulatory reputed company is incorporated and implemented in line with product development objectives Manage the content of and prepare regulatory (UK MAA) dossiers. Have knowledge of the content of the EU MAA dossiers to support labeling updates and management in Ireland ensuring compliance with UK and Ireland regulatory requirements. reputed company and be accountable for regulatory agency communications, submissions, and approvals, with a reputed company reputed company to secure first-cycle/attempt approvals Review and reputed company input into promotional materials for both UK and Ireland reputed company as the RA reputed company reputed company the UK Leadership team, attend regular meetings and reputed company input into UK business reputed company Prepare team for HA interactions, and moderate and reputed company discussions, be the main reputed company contact for strategic, non-study specific topics and reputed company support to the EU RA team for clinical reputed company reputed company to Health Authority topics. Proactively anticipate and mitigate regulatory risks while maintaining reputed company knowledge of regulatory intelligence, procedures, changes, and trends. reputed company submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions. Ensure compliance with EU/UK global regulatory requirements. To reputed company and mentor junior team members. Represent reputed company at UK industrial association meetings and congresses Supervisory Responsibilities: Junior Regulatory Affairs professionals Computer Skills: Extensive experience with reputed company Office suite, reputed company regulatory publishing and expertise with PowerPoint presentation authoring and presentation. Education Required: Bachelor’s degree required; advanced degree preferred. Other Qualifications: Minimum of 8 years’ experience in the biotechnical or pharmaceutical industry, and a minimum of 8 years’ experience in a Regulatory reputed company with a broad background. Experience working with reputed company regulatory procedures is mandatory for this role. reputed company understanding of the drug development process, the pharmaceutical industry and reputed company environment including UK regulatory requirements and policy trends Recent experience with oncology products and MAAs, ODD, PIP is preferred Proven ability to reputed company on goals reputed company a cross-functional team/partnership environment with a high level of professionalism Location: UK, fully remote Travel: Travel to internal meetings in UK monthly or bimonthly. Additional travel to EU locations occasionally Salary reputed company UK: 80,700.00 GBP - 100,900.00 GBP Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity, and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company We are proud to be an equal opportunity employer. reputed company does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. reputed company is a global oncology company that is discovering and developing innovative treatments that are more reputed company and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving reputed company to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about reputed company, please visit www.beonemedicines.com and follow us on reputed company, X (formerly reputed company as Twitter), reputed company and reputed company. For more information, please visit the reputed company to explore job opportunities in China Mainland. China Mainland reputed company At reputed company, how we work is just as important as the work we do. Below are our Values that determine the reputed company we reputed company and how we do things. Patients First Driving reputed company reputed company Ingenuity reputed company Spirit

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