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- Tasks: Lead and manage RA CMC strategies for innovative healthcare products.
- Company: Mundipharma is a global healthcare company focused on patient-centric treatments.
- Benefits: Enjoy a flexible benefits package and opportunities for learning & development.
- Why this job: Join a collaborative team making a positive impact in healthcare.
- Qualifications: Requires a scientific degree and proven experience in regulatory or technical CMC.
- Other info: Home working with occasional travel to Cambridge.
The predicted salary is between 72000 - 108000 £ per year.
ARA-M4-14 Location: Cambridge (Home working with some travels to Cambridge when needed) Job type: Permanent At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. We are looking for a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The person will also be responsible for building and maintaining a strong collaborative partnership with products teams especially with team members from Tech Ops and Quality. They will act as Senior Oversight for RA CMC activities and ensure effective, quality delivery of CMC support from vendors.They will also lead a team of permanent employees (CMC regulatory) and supervise contractors and consultants supporting the CMC regulatory objectives and deliverables. Key Responsibilities Responsible for RA CMC for products including RA CMC strategy and oversight of vendor delivery. Ensure that RA CMC strategies fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate product team decision making. Escalation point for vendors for RA CMC strategy for products and review of delivery output from vendors to ensure that it is fit for purpose and in line with the strategic direction provided. Act as initial escalation point for Product/Process related RA CMC queries from within the organisation and from vendors for marketed products. Provision of RA CMC support for Due Diligence. Responsible for RA CMC focused agency negotiations and interactions, including scientific advice. Lead a team of permanent employees within CMC regulatory. Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio. Provide and drive the direction of the RA CMC service provided to the Mundipharma companies and partners by vendors. Qualifications Scientific based degree Proven pharmaceutical experience in regulatory or technical CMC CMC technical experience Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management. Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners. Strong organisation and problem solving skills. Self-motivated, driven with a positive attitude. Excellent communicator and collaborator with strong customer and stakeholder focus. Ability to effectively motivate and manage a team to deliver RA CMC objectives What we offer in return flexible benefits package opportunities for learning & development collaborative, inclusive work environment Diversity and inclusion Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients. About Mundipharma Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do. Join our talent pool If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles. Additional Job Description: Primary Location: GB Cambridge Job Posting Date: 2024-09-06 Job Type: Permanent #J-18808-Ljbffr
Director of CMC for Marketed Products employer: Mundipharma
Contact Detail:
Mundipharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of CMC for Marketed Products
✨Tip Number 1
Familiarize yourself with the latest trends and regulations in RA CMC. This will not only help you understand the role better but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in regulatory affairs and CMC. Attend relevant conferences or webinars to make connections that could lead to valuable insights and opportunities.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed CMC strategies in the past. Highlight your experience in leading teams and collaborating with vendors, as these are crucial aspects of the role.
✨Tip Number 4
Showcase your problem-solving skills by thinking of potential challenges Mundipharma might face in RA CMC and how you would address them. This proactive approach can set you apart from other candidates.
We think you need these skills to ace Director of CMC for Marketed Products
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Director of CMC for Marketed Products. Understand the key responsibilities and qualifications required, and think about how your experience aligns with these.
Tailor Your CV: Customize your CV to highlight relevant pharmaceutical experience in regulatory or technical CMC. Emphasize your leadership skills and any experience managing teams, as well as your knowledge of RA CMC strategies.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for innovative treatments and your ability to collaborate effectively with internal and external partners. Mention specific examples of how you've successfully managed CMC objectives in the past.
Highlight Your Soft Skills: In your application, make sure to emphasize your strong organization, problem-solving skills, and ability to motivate a team. These soft skills are crucial for the role and should be clearly articulated in your documents.
How to prepare for a job interview at Mundipharma
✨Understand the CMC Landscape
Make sure you have a solid grasp of the current trends and challenges in Chemistry Manufacturing Control (CMC). Be prepared to discuss how these factors influence regulatory strategies and vendor management.
✨Showcase Your Leadership Skills
As a Director, you'll be leading a team. Highlight your experience in managing teams, setting clear objectives, and driving performance. Share specific examples of how you've motivated and developed team members in previous roles.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and decision-making skills. Prepare to discuss real-life scenarios where you had to navigate complex regulatory challenges or vendor issues, and how you resolved them.
✨Emphasize Collaboration and Communication
Given the importance of collaboration with internal and external partners, be ready to discuss your approach to building strong relationships. Provide examples of how you've effectively communicated with stakeholders to achieve common goals.
