About the role
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
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 oversight and management of commercial products for both UK and Ireland.
Essential Functions of the job:
This individual will lead the UK RA team to manage regulatory aspects of designated compounds (NME/New indications) through all phases of development, registration, post-approval, and lifecycle of the product as detailed below:
Collaborate with key internal stakeholders to define UK MAA strategy and ensure the regulatory strategy 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. Oversee and be accountable for regulatory agency communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals
Review and provide input into promotional materials for both UK and Ireland
Act as the RA liaison within the UK Leadership team, attend regular meetings and provide input into UK business strategy
Prepare team for HA interactions, and moderate and lead discussions, be the main MHRA contact for strategic, non-study specific topics and provide support to the EU RA team for clinical matters related to Health Authority topics.
Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory intelligence, procedures, changes, and trends.
Provide 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 lead and mentor junior team members.
Represent BeOne at UK industrial association meetings and congresses
Supervisory Responsibilities:
Junior Regulatory Affairs professionals
Computer Skills: Extensive experience with Microsoft Office suite, Veeva 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 capacity with a broad background.
Experience working with MHRA regulatory procedures is mandatory for this role.
Sound understanding of the drug development process, the pharmaceutical industry and healthcare environment including UK regulatory requirements and policy trends
Recent experience with oncology products and MAAs, ODD, PIP is preferred
Proven ability to deliver on goals within 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 Range UK: 80,700.00 GBP - 100,900.00 GBP
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Originally posted on Himalayas