Senior Manager, CMC-Regulatory - Permanent Position
Senior Manager, CMC-Regulatory - Permanent Position
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Job Description
Senior Manager CMC-Regulatory - Permanent Position
The Company
Eisai 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 role
We 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 for
- College 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.) preferably
- including some broader industry/academia experience
- Possess working knowledge on the formulation and/or analytical aspects of R&D in addition to the above CMC-regulatory related experience
- A working knowledge on the principles of chemistry/biochemistry to drug substance manufacture
- Experience 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 return
Eisai offers a competitive salary and excellent wider benefits package that includes
- Hybrid working (Depending on role)
- Car/Car Allowance (Depending on role)
- Electric charging points for Electric/Hybrid vehicles
- Discretionary Bonus
- Free onsite parking
- Subsidised onsite restaurant and coffee shop
- Learning and development opportunities
- Retail discounts
- Well-being & mental health awareness programmes
- Multi-faith prayer room
You 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 next
If 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 Statement
Diverse 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 Statement
We 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 integrity
Required Experience:
Senior Manager
Employment Type
Full-Time
