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Head of Regulatory CMC

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POST DATE 9/7/2016
END DATE 10/13/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Senior (15+ years)
Masters Degree


Job Description

Provide a brief summary describing the major role, responsibility and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.
Accountable for setting the overall regulatory CMC strategy that delivers solutions and
success for the entirety of shires pipeline of pipeline and in line products. Responsible for driving and ensuring a coordinated strategic global approach to CMC throughout all phases of a product life-cycle and registration including biologics, blood products, small molecules, devices, and gene/cell therapy. Overall accountability to:

Strategic and operational leadership of a global organizations and accountability for the regulatory strategy and execution of both internal and external manufacturing.
Develop relationships internal and external with key stakeholders and
Lead and take accountability for multiple people, regions, projects, platforms and department initiatives.
Work collaboratively with other senior leaders within R&D, Tech Ops, and the business to drive overall shire strategy and help ensure continued product supply.

Demonstrated leadership qualities
The highest standards of technical excellence
The ability to introduce new ways of working and process excellence.
Create a high performing collaborative culture within Reg CMC, Regulatory affairs, and Shire.
Have a strong foundation of global needs and multiple platform technologies
Ability to quickly and effectively integrate new companies, programs, and people.

Lead, build, motivate and develop a team of CMC regulatory personnel providing guidance of CMC issues and internal work processes.

Represent Shire with external stakeholders and leading policy and advocacy initiatives in support of Shire s objectives.
Describe the essential daily job functions and include % of time spent on each.

Strategic leader of the global regulatory CMC function to ensure
a global coordinated consistent approach to CMC for all products at all phases of development and registration including biologics, small molecules, devices, and cell therapy. As a member of key leadership teams in Reg Affairs and Tech Ops, work effectively with colleagues to set and meet or exceed strategic goals and objectives. Key member of cross functional manufacturing councils to provide senior oversight to shires development and in line products.

Provide regulatory senior leadership to internal partners in product development, Quality and Manufacturing and to the CMC regulatory personnel, setting a clear vision. Review and approve technical documentation including protocols, reports and other documents destined for CMC submissions or available upon regulatory inspection.

Lead the regulatory aspects related to chemistry, manufacturing and controls, for new and existing products/projects. Ensure the development of robust, global CMC strategies to ensure identification of key issues. Leads the development of risk assessment and mitigation plans.
Shire s Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

Provide timely and robust leadership in business development as it related to the CMC aspects of this process. Effectively identify risks and mitigations for these activities. Work collaboratively with other shire colleagues to critically assess external opportunities. Build and maintain a strong network of external experts to assist in areas Shire may not have subject matter expertise.
Strong focus on culture and people. Effectively build a culture
of collaboration and trust within the CMC and larger shire teams. Lead and support department initiatives. Champion a culture of trust and compliance. Challenges accepted ways of working to drive innovation in the way we think and work. Foster a culture of high performance from the CMC team and all those within Shire.
Other responsibilities:

Mentoring employees/consultants.
Interviewing, hiring and training employees/consultants.
Aggregating resource forecasts for projects/programs.
Planning, assigning and directing work.
Setting objectives and appraising performance.
Developing risk management plans and overseeing implementation of risk mitigation activities.
Managing performance assessments and career development activities.
Establishing team objectives and developing team scorecard.
Monitoring team metrics and ensuring team deliverables against scorecards.
Mentoring GRA colleagues across the department.


Ph.D. / M.S. in chemistry or related discipline. Minimum of 15 years experience in regulatory CMC. Proven experience of leading a team at a senior level and working and influencing globally.

A balance of experience in development and commercial CMC regulatory activities in the

US, EU and other key markets.

Understanding of biologics, small molecules, devices, and cell therapy preffered


Ability to travel domestically and globally and sometimes frequently (once a month)

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.