At a Glance
- Tasks: Develop and implement regulatory strategies for global projects in respiratory and immunology.
- Company: Join GSK, a leading biopharma company with a mission to impact global health.
- Benefits: Enjoy competitive salary, bonuses, health benefits, and flexible working arrangements.
- Other info: Hybrid work model with opportunities for career growth and development.
- Why this job: Be part of a team that aims to positively impact the health of 2.5 billion people.
- Qualifications: Degree in a relevant field and experience in regulatory affairs required.
The predicted salary is between 138600 - 231000 £ per year.
Key Responsibilities
- Proactively develop regulatory strategies that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
- Implement the regional strategy(s) in support of the project globally.
- Manage regulatory interactions and the review processes in local regions.
- Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
- Ensure compliance with global/regional requirements at all stages of product life.
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.
Location
The successful applicant can be based at GSK HQ (London), Wavre (Belgium) or Upper Providence, Durham or Rockville (USA).
About You
This role is a great opportunity to be instrumental in developing and delivering subject matter expertise across GSK. As this role is multi-faceted and includes liaising with a wide variety of key stakeholders you must have strong experience of working in complex technical situations, with demonstrable clear problem-solving approach to your work. Strong people skills and a proven ability to influence people to achieve and drive performance are also prerequisites for this role.
Basic Qualifications
- Degree-educated in relevant scientific or technical discipline (or very strong relevant experience).
- Relevant regulatory affairs experience in the EU and/or US and other major markets.
- Experience should include, for example, developing and implementing regional strategies, managing regulatory interactions, submissions, and review processes.
- Clinical regulatory experience is a must, with knowledge of all phases of the drug development process.
- Ability to develop necessary specialist knowledge for the product or area of medicine.
- Proficiency in digital tools and AI to enhance project delivery and drive efficiency and innovation.
Preferred Qualifications
- Experience of all phases of the drug development process in regulatory affairs.
- Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
- Experience in relevant therapy area (especially Immunology & Inflammation) is a plus.
Work arrangement
This role is hybrid. Regular on-site collaboration is mandatory. Typical schedule will be two to three days on-site per week.
Skills
- Business Resilience
- Communication
- Digital Fluency
- Matrix Leadership
- Pharmaceutical Regulatory Compliance
- Policy Advocacy
- Regulatory Strategies
- Resource Management
- Stakeholder Management
Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation) in London employer: GlaxoSmithKline plc
GSK is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals seeking to make a meaningful impact in the biopharma industry. With a commitment to employee growth through continuous learning opportunities and a flexible hybrid working model, GSK empowers its workforce to thrive while contributing to groundbreaking advancements in healthcare. Located in vibrant London, employees benefit from a dynamic work environment that prioritises ambition for patients and accountability for results.
StudySmarter Expert Advice🤫
We think this is how you could land Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation) in London
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We think you need these skills to ace Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation) in London
Some tips for your application 🫡
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