My client, a leading Japanese Pharmaceutical company is seeking a Regulatory CMC professional to join their team on a permanent basis as a Senior Manager of Regulatory Affairs CMC.
They are seeking someone to-
· Guide the Global RA-CMC group as a member of senior staff.
· Envisage the pharmaceutical industry environment and prepare for the future risks from RA perspective.
· Lead the preparation of submission documents (IMPDq, Module 3 for MAA or license variations and respond to questions from health authorities in timely fashion and with exacting clarity.
· Have accountability for the quality of submissions as will be assessed by health agencies.
Main duties/responsibilities:
Responsibilities include but are not limited to:
· For assigned topics to meet high quality CMC writing or compilation to meet project key milestones and timings.
· Assumes regulatory accountability for the CMC aspects of the projects/products goals and objectives.
· Provides oversight for the CMC components of all regulatory submissions (IND or CTA, NDA or MAA, amendments, variations, scientific advice briefing documents, CMC agency communications etc.) to ensure that quality documents are prepared in compliance with the applicable regulatory requirements.
· Engages or leads in CMC sub-teams to plan, prepare and complete the CMC section of major submissions.
· Leads effective responses to Health Agency CMC questions.
· Engages in regional/national health agency meetings for CMC related discussions.
· Interacts with and Influences external stake holders.
· Engages with patients reality socialization human health care (HHC) activity.
· Accountable for the quality and compliance of CMC aspects of all submissions made by GR-CMC.
· Supports regulatory strategy and manages timelines to meet project needs.
· Has responsibility that the approval of work submitted by any junior staff/ consultants relating to CMC aspects of submissions is demonstrated,
· Interacts with external stakeholders regarding CMC regulatory issues.
Person Specification:
Qualifications, education and language requirements:
· College or University degree required in associated functional discipline (Chemistry or Pharmacy)
· Doctorate or higher degree desired (e.g. MSc, JD, Pharm D, or PhD in life sciences)
Experience Required:
· Extensive regulatory experience plus additional related experience (i.e., in Research and Development or Manufacturing, clinical marketed products, etc.), preferably including some broader industry experience
· An accomplished working knowledge of both the formulation and analytical aspects of R&D in addition to the above regulatory experience
· A strong working knowledge of the application of the principles of chemistry to drug synthesis
· Experience of the development of solid, liquid and parenteral dosage forms, including process validation.
· Experience dealing with agencies, preparation of briefing documents and holding agency meetings relating to Quality issues.
Skills and Aptitude Required:
· Ability to express a scientific opinion clearly and concisely and to defend regulatory decisions under pressure
· High organisational skills and time management
· Confidence in dealing with Regulatory Authorities
· Ability to manage multiple projects and multiple tasks in balance
· Ability to work in a matrix environment
If you would like to apply for this position or would like more information on it, please email me on rosa.mackenzie@srg.co.uk or call me on 0207 562 1704
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
