GSK - Regulatory Affairs Specialist - Submission Coordination (5-7 yrs)
- Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization? If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.
- As Regulatory Operations professional, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.
- This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Accountable to Project Lead or GRL/ Regional Rep/ C&EP lead for delivery of assigned submissions to agreed timeframes and appropriate content
- With minimal input from manager, manages multiple project assignments (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) simultaneously; dossiers will range in complexity
Ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.
- Works with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
- Plans, communicates and executes activities with minimal input from manager
- We are looking for an experienced individual and if you have these skills, we would like to speak to you.
- Minimum 5-7 years of EU and EMAP regulatory experience
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities, Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
Note: For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well.