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- Tasks: Lead regulatory submissions and strategy for product development in a dynamic environment.
- Company: Join a company that values growth, safety, and inclusivity in the workplace.
- Benefits: Enjoy competitive salary, annual bonuses, healthcare, hybrid work options, and pension plans.
- Why this job: Shape regulatory strategies while mentoring others in a role that impacts global compliance.
- Qualifications: Experience in regulatory affairs with a focus on CMC is essential.
- Other info: Flexible working model allows you to balance remote and in-office work.
The predicted salary is between 43200 - 72000 £ per year.
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Manager/Associate Director – Regulatory Affairs, CMC
View more categories View less categories Sector Legal Role Manager Contract Type Permanent Hours Full Time
Site Name: UK – London – New Oxford Street, Switzerland – Zug, UK – Hertfordshire – Stevenage
Posted Date: Jan 14 2025
Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs CMC role could be an ideal opportunity to explore.
As a Regulatory Affairs Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the UK.
Depending on candidate’s experience we will offer Manager or Associate Director level role.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
In this role you will
- Drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, ensuring compliance with evolving regulatory requirements. Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation strategies.
- Mentor or train staff, manage project activities for multiple complex projects and teams simultaneously, and provide strategic direction, data assessment and conclusions within and across departments.
- Engage CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).
- Deliver CMC regulatory strategy to support major inspections and quality incidents.
- Ensure submission content complies with regulations, expediting review and approval of global CMC applications. Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation
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Manager/Associate Director - Regulatory Affairs, CMC employer: ENGINEERINGUK
Contact Detail:
ENGINEERINGUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager/Associate Director - Regulatory Affairs, CMC
✨Tip Number 1
Familiarize yourself with the latest regulatory guidelines and frameworks specific to CMC in the UK. This knowledge will not only help you understand the role better but also demonstrate your commitment and expertise during discussions.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in CMC. Engaging with industry experts can provide valuable insights and potentially lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed regulatory submissions or navigated complex compliance issues in past roles. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Stay updated on current trends and challenges in the regulatory landscape, particularly those affecting CMC. Being able to speak knowledgeably about these topics during your interview will show that you're proactive and well-informed.
We think you need these skills to ace Manager/Associate Director - Regulatory Affairs, CMC
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Manager/Associate Director - Regulatory Affairs, CMC position. Understand the key responsibilities and required skills to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulatory affairs, particularly in CMC. Provide specific examples of past projects where you drove strategy or managed complex submissions.
Showcase Leadership Skills: Since this role involves mentoring and managing project activities, highlight any leadership experiences you have. Discuss how you've successfully led teams or projects in the past.
Tailor Your Application: Customize your cover letter to reflect your understanding of the company's values and how you can contribute to their goals. Mention your alignment with their hybrid working model and commitment to compliance and quality.
How to prepare for a job interview at ENGINEERINGUK
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulatory frameworks relevant to CMC submissions. Be prepared to discuss how you have navigated these regulations in past roles and how you would apply this knowledge in the new position.
✨Showcase Your Strategic Thinking
This role requires a strategic mindset. Prepare examples of how you've developed and implemented regulatory strategies in previous positions, particularly those that led to successful submissions or mitigated risks.
✨Demonstrate Leadership Skills
As a Manager/Associate Director, you'll be expected to mentor and lead teams. Share specific instances where you've successfully managed projects or guided team members, highlighting your leadership style and its impact on project outcomes.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities. Think through potential challenges related to CMC submissions and prepare to discuss how you would address them, including risk identification and mitigation strategies.
