Location: Hertfordshire (homeworking offered)
Salary: Highly competitive + benefits
employment: full time, permanent
Job reference:
Regulatory Professionals are collaborating with a global pharmaceutical company that focuses on Neurology, Oncology, and infectious diseases treatments. Our client is looking for an experienced Senior Manager, CMC-Regulatory to join their vibrant team in Hertfordshire. In this role, you will be responsible for providing CMC-regulatory services to support our client’s success worldwide and provide CMC-regulatory support for established products including growth market submissions and any post-approval activities.
Main duties/responsibilities:
Responsibilities will include but not be limited to:
Regulatory
- Ensures the quality of deliverables and services to stakeholders for multiple projects/products.
- Take measures to keep our client's development projects and established product away from regulatory risk.
- Provide CMC-regulatory advice to project members.
- Have a good knowledge of quality guidelines and how to apply them.
CMC/Quality
- Establish CMC-regulatory strategy for projects/products.
- Lead preparation of CMC-regulatory documents.
- Attend CMC-regulatory meetings to solve issues on CMC/Quality for development or marketed projects.
- Lead preparation of Module 3 sections.
- Review changes proposed by QA/manufacturing and take any necessary CMC-regulatory actions to implement the changes.
- Liaise with affiliates/distributors in new markets on CMC-regulatory issues.
Development
- Evaluate CMC-regulatory processes and propose solutions to improve our client’s CMC-regulatory activities.
- Propose how our client can be a patient-oriented hhc company.
Qualifications, education, and language requirements:
- 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)
Experience Required:
- 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
- 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.
Skills and Aptitude Required:
- Ability to express a scientific opinion clearly and concisely.
- Able to defend CMC-regulatory advice under pressure.
- Able to manage conflicting guidance and provide solutions.
- Flexible and adaptable. Open to a changing environment.
- Organizational and time management skills.
- Confidence in dealing with Regulatory Authorities.
- Ability to manage multiple projects and multiple tasks.
- Ability to work in a matrix environment.
If you would like to apply for this position, please contact Amani via amani@regulatoryprofessionals.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you £250 worth of vouchers *terms and conditions apply*
