At a Glance
- Tasks: Lead regulatory strategies for innovative healthcare products and engage with global health authorities.
- Company: Join a leading global pharmaceutical company dedicated to healthcare innovations.
- Benefits: Competitive salary, professional development, and a collaborative work environment.
- Other info: Inclusive culture with opportunities for career advancement in the STEM sector.
- Why this job: Make a real impact on global health while shaping regulatory strategies for pioneering products.
- Qualifications: 10+ years in Regulatory Affairs with experience in leadership and stakeholder engagement.
The predicted salary is between 100000 - 150000 € per year.
We are currently looking for a Senior Director of Regulatory Strategy and Labelling Lead to join a leading global pharmaceutical company supporting global healthcare innovations. This exciting opportunity offers the chance to shape and drive our client's regulatory strategies across a diverse portfolio of assets, ensuring compliance, optimal labelling, and robust interactions with regulatory authorities worldwide. You will play a pivotal role in leading strategic initiatives and guiding senior leadership decisions to achieve superior regulatory outcomes. This role is ideal for a strategic thinker with extensive experience in regulatory affairs and experience in leadership.
KEY DUTIES AND RESPONSIBILITIES
- Provide overall regulatory strategic leadership for all products, including the development and deployment of expertise to meet portfolio regulatory deliverables and lifecycle management goals.
- Lead the creation and execution of global regulatory strategies for the portfolio, ensuring alignment with corporate objectives, CMC considerations, and market needs.
- Proactively engage with internal stakeholders and senior leadership to develop regulatory strategies that support commercial and development goals, including external engagement with health authorities and expert consultants.
- Ensure regulatory strategies encompass risk mitigation plans, clearly communicating these risks and mitigations internally to guide decision-making.
- Oversee interactions with global regulatory authorities, ensuring clear understanding of feedback and requirements, and effectively integrating these into strategic plans.
ROLE REQUIREMENTS
- A Degree or higher level in a relevant field (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management for QA roles).
- Proven track record of more than 10 years in Regulatory Affairs strategy, with experience in developing and implementing innovative regulatory plans across diverse product portfolios.
- Extensive experience engaging with global regulatory agencies such as EMA, FDA, BfArM, MHRA, TGA, and PMDA.
- Demonstrated ability to lead collaborative initiatives, influence senior stakeholders and develop and manage teams.
WHAT'S IN IT FOR YOU?
Joining our client means stepping into a leadership role where your expertise will directly impact global health, working within a committed and inclusive environment. You will have the opportunity to shape regulatory strategies for pioneering products, develop your leadership skills, and influence best practices within the industry. Competitive benefits, ongoing professional development, and a collaborative culture await the successful candidate.
Senior Director Regulatory Strategy & Labelling Lead in Leeds employer: LinkedIn
Join a leading global pharmaceutical company where your role as Senior Director of Regulatory Strategy and Labelling Lead will not only shape regulatory strategies for innovative healthcare solutions but also foster a collaborative and inclusive work culture. With competitive benefits and ample opportunities for professional development, you will be empowered to influence best practices and drive impactful decisions that enhance global health outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Director Regulatory Strategy & Labelling Lead in Leeds
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those involved in regulatory affairs. A friendly chat can lead to insider info about job openings or even referrals that could give you an edge.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory agencies and their requirements. We recommend creating a cheat sheet of key regulations and recent changes that could impact your potential employer's portfolio.
✨Tip Number 3
Showcase your leadership skills during interviews. Be ready to discuss specific examples where you've influenced senior stakeholders or led successful initiatives. This is your chance to shine and demonstrate how you can drive strategic outcomes.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our platform.
We think you need these skills to ace Senior Director Regulatory Strategy & Labelling Lead in Leeds
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in regulatory affairs and leadership. Use keywords from the job description to show that you’re a perfect fit for the Senior Director role.
Craft a Compelling Cover Letter:Your cover letter should tell a story about your journey in regulatory strategy. Highlight specific achievements and how they align with the responsibilities of the role. This is your chance to shine!
Showcase Your Stakeholder Engagement Skills:In both your CV and cover letter, emphasise your experience engaging with global regulatory agencies and senior stakeholders. We want to see how you’ve influenced decisions and led teams in the past.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at LinkedIn
✨Know Your Regulatory Landscape
Before the interview, brush up on the latest trends and regulations in the pharmaceutical industry. Familiarise yourself with the specific regulatory agencies mentioned in the job description, like EMA and FDA, and be ready to discuss how your experience aligns with their requirements.
✨Showcase Your Strategic Thinking
Prepare examples that highlight your ability to develop and implement innovative regulatory strategies. Think about past projects where you led initiatives or influenced senior stakeholders, and be ready to share these stories during the interview.
✨Engage with Stakeholders
Demonstrate your experience in engaging with internal and external stakeholders. Be prepared to discuss how you've successfully collaborated with teams and health authorities to achieve regulatory goals, as this will show your ability to lead and influence.
✨Communicate Clearly About Risks
Since risk mitigation is a key part of the role, think about how you've identified and communicated risks in previous positions. Be ready to explain your approach to risk management and how it has shaped decision-making in your past roles.
