At a Glance
- Tasks: Lead regulatory strategies for innovative healthcare products and engage with global authorities.
- Company: Join a leading global pharmaceutical company committed to healthcare innovations.
- Benefits: Competitive salary, professional development, and a collaborative work environment.
- Other info: Inclusive culture with opportunities for career advancement.
- Why this job: Shape the future of global health and influence industry best practices.
- Qualifications: 10+ years in Regulatory Affairs with leadership experience and a relevant degree.
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 RESPONSIBILITIESYour duties as the Senior Director of Regulatory Strategy and Labelling Lead will be varied however the key duties and responsibilities are as follows:
- 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.
To be successful in your application to this exciting role as the Senior Director of Regulatory Strategy and Labelling Lead we are looking to identify the following on your profile and past history:
- 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.
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 employer: Hyper Recruitment Solutions LTD
As a leading global pharmaceutical company, we pride ourselves on fostering a dynamic and inclusive work environment where innovation thrives. Our commitment to employee growth is reflected in our robust professional development programmes and the opportunity to influence global health through strategic regulatory initiatives. Join us to be part of a collaborative culture that values your expertise and offers competitive benefits, ensuring you can make a meaningful impact in the healthcare sector.
Contact Details:
Hyper Recruitment Solutions LTD Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Director Regulatory Strategy & Labelling Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory agencies like EMA and FDA. Be ready to discuss how your past experiences align with the strategic goals of the company you're applying to.
✨Tip Number 3
Showcase your leadership skills! During interviews, share specific examples of how you've led teams or projects in regulatory strategy. Highlight your ability to influence senior stakeholders and drive successful 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 about their job search.
We think you need these skills to ace Senior Director Regulatory Strategy & Labelling Lead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the key skills and experiences mentioned in the job description. Highlight your regulatory affairs experience and any leadership roles you've held, as this will show us you're a great fit for the Senior Director position.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory strategy and how your background aligns with our needs. Be sure to mention specific achievements that demonstrate your expertise in engaging with global regulatory agencies.
Showcase Your Strategic Thinking:In both your CV and cover letter, emphasise your ability to develop and implement innovative regulatory plans. We want to see examples of how you've led strategic initiatives and influenced senior stakeholders in your previous roles.
Apply Through Our Website:We encourage you to apply directly through our website. This ensures your application gets to the right people quickly and allows us to keep track of all applicants efficiently. Plus, it shows us you're keen on joining our team!
How to prepare for a job interview at Hyper Recruitment Solutions LTD
✨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 regulatory strategies. Think about past projects where you led initiatives or influenced senior stakeholders, and be ready to explain your thought process and the outcomes achieved.
✨Engage with Stakeholders
Demonstrate your experience in stakeholder engagement by discussing how you've successfully collaborated with internal teams and external authorities. Be prepared to share specific instances where your communication skills made a difference in achieving regulatory goals.
✨Risk Management is Key
Since risk mitigation is a crucial part of the role, come prepared to discuss how you've identified and managed risks in previous projects. Highlight your approach to communicating these risks to stakeholders and how it influenced decision-making.
