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- Tasks: Lead CMC-regulatory projects and ensure stakeholder satisfaction while supporting drug development.
- Company: Join Eisai, a top research-based pharmaceutical company focused on patient-first healthcare.
- Benefits: Enjoy hybrid working, competitive salary, well-being programmes, and learning opportunities.
- Why this job: Be part of a collaborative culture that values diversity and innovation in healthcare.
- Qualifications: Degree in Chemistry, Biological Science, or Pharmacy; experience in CMC-regulatory required.
- Other info: Work from our inclusive EMEA Knowledge Centre with excellent facilities.
The predicted salary is between 60000 - 84000 £ per year.
Senior Manager CMC-Regulatory – Permanent Position The CompanyEisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology Neurology and Pain therapy areas.By joining Eisai you will be working for an organisation with a human healthcare philosophy which means that we put the patient first in everything we do.Your new roleWe have an exciting opportunity for a Senior Manager CMC-Regulatory you will:Provide CMC-regulatory services to support Eisais success worldwide. Be accountable for execution of multiple projects and stakeholders satisfaction. Collaborate with IPT and CMC teams supporting development projects towards license submission and approval.Provide CMC-regulatory support for established products including growth market submissions and any post-approval activities relevant to the drug substance and/or drug product. What are we looking forCollege or University degree in an associated functional discipline (Chemistry Biological Science or Pharmacy)Doctorate or higher degree desired (e.g. MSc JD Pharm D or PhD in life sciences)Previous CMC-regulatory-related experience plus additional related experience (i.e. in Research and Development or Manufacturing Quality Assurance Quality Control etc.) preferablyincluding some broader industry/academia experiencePossess working knowledge on the formulation and/or analytical aspects of R&D in addition to the above CMC-regulatory related experienceA working knowledge on the principles of chemistry/biochemistry to drug substance manufactureExperience in the development of solid and/or parenteral dosage forms including process validation.Experience dealing with agencies preparation of briefing documents and holding agency meetings relating to CMC/Quality issues. What we offer in returnEisai offers a competitive salary and excellent wider benefits package that includesHybrid working (Depending on role)Car/Car Allowance (Depending on role)Electric charging points for Electric/Hybrid vehiclesDiscretionary BonusFree onsite parkingSubsidised onsite restaurant and coffee shopLearning and development opportunitiesRetail discountsWell-being & mental health awareness programmesMulti-faith prayer roomYou will also be based out of our excellent EMEA Knowledge Centre (EKC) facility which is our EU Headquarters and offers an inclusive and collaborative working environment.What you need to do nextIf you are interested in this position please click apply now at the top of this advert. Upon submitting your application you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application.If you have any questions please contact us on Eisai Recruitment StatementDiverse perspectives and experiences are critical to our success and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.Eisai EMEA EDI Commitment StatementWe believe that diverse and inclusive teams promote wellbeing learning and innovation helping Eisai serve our patients their families our employees and society. Our commitment is:to embrace and celebrate our differences respecting and valuing each other.to include equity diversity and inclusion practices in all that we do so everyone has a full sense of belonging.to value individual talent where every employee can be themselves and thrive in an environment of openness trust and integrityRequired Experience:Senior Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1
Senior Manager, CMC-Regulatory - Permanent Position employer: Dr Jobs
Contact Detail:
Dr Jobs Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, CMC-Regulatory - Permanent Position
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in CMC-regulatory roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements and guidelines relevant to CMC in the pharmaceutical sector. Understanding the nuances of FDA regulations and other global standards will give you an edge during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in managing multiple projects and stakeholder relationships. Be ready to provide examples of how you've successfully navigated complex regulatory environments and contributed to product approvals.
✨Tip Number 4
Showcase your knowledge of both analytical and formulation aspects of drug development. Highlight any specific projects where you contributed to solid or parenteral dosage forms, as this will demonstrate your hands-on experience in the field.
We think you need these skills to ace Senior Manager, CMC-Regulatory - Permanent Position
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in CMC-regulatory roles, particularly in the pharmaceutical industry. Emphasise your educational background in Chemistry, Biological Science, or Pharmacy, and any advanced degrees you may hold.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for patient-first healthcare and your understanding of Eisai's mission. Mention specific projects or experiences that demonstrate your ability to manage multiple stakeholders and deliver results in a regulatory context.
Highlight Relevant Skills: In your application, clearly outline your skills related to FDA regulations, manufacturing controls, and product development. Use specific examples to illustrate your experience with agency meetings and preparation of briefing documents.
Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter for any errors. A polished application reflects your attention to detail, which is crucial for a Senior Manager in CMC-Regulatory.
How to prepare for a job interview at Dr Jobs
✨Showcase Your CMC-Related Experience
Make sure to highlight your previous experience in CMC-regulatory roles. Be prepared to discuss specific projects you've worked on, particularly those involving drug substance and product development, as well as any interactions with regulatory agencies.
✨Demonstrate Your Technical Knowledge
Brush up on your understanding of chemistry and biochemistry principles related to drug manufacture. Be ready to explain how your technical skills can contribute to the formulation and analytical aspects of R&D.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about challenges you've faced in past roles and how you successfully navigated them, especially in relation to agency meetings or quality issues.
✨Emphasise Collaboration Skills
Since the role involves working with various teams, be sure to illustrate your ability to collaborate effectively. Share examples of how you've worked with cross-functional teams to achieve project goals and ensure stakeholder satisfaction.