Shire CMC Regulatory Affairs Lead in Lexington, Massachusetts
The CMC Regulatory Affairs Associate Director will provide leadership and will oversee
the registration of existing Shire products that will be manufactured at sites in countries
where the products will be distributed. The AD will be the Regulatory CMC point of
contact for these major projects and will collaborate with local RA and RegCMC
Strategists on the preparation of dossier that will be submitted by local RA to health
authorities. The AD will collaborate with local RA on formulating and implementing CMC
regulatory strategies in line with local requirements, using contemporary submission
standards for Modules 2.3/3.
Collaborate with regulatory colleagues in Global Regulatory Affairs (GRA) to ensure
global perspective and provide support in the implementation of RegCMC business
initiatives. Responsibilities include:
o Process and excellence lead
o Provide oversight on initiatives and workstreams, internal and external to GRA
o Provide oversight of communications to SME stakeholders, including RegCMC
Primary role includes:
o Serve as the team lead
o Serve as a liaison between local RA and the GRA CMC Product Lead
o Provide CMC RA leadership within RA and on in-country cross-functional CMC
o Maintain up-to-date knowledge and expertise of relevant FDA, ICH and local
country guidelines and regulations
Collaborate with local RA and provide CMC regulatory strategy for proposed changes or
other related activities for in country commercial programs. (40%)
Optimize RegCMC business operations, such as the RegCMC Sharepoint Site, trackers
for CMC Submission rework, and other initiatives that improve operational efficiencies in
RegCMC. Brand RegCMC for internal and external stakeholders. (40%)
Collaborate with local RA and co-lead other functions for timely preparation of high
quality regulatory submissions including CMC sections of local regulatory dossiers and
respective amendments/supplements. (20%)
Education and Experience Requirements
B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related
7 - 10 years of drug development experience including and/or significant strategic
experience in CMC regulatory affairs with a strong biologics background.
Demonstrated leadership in regulatory strategy and experience in regulatory interactions
Key Skills, Abilities, and Competencies
Ability to manage complex projects, timelines and teams in a matrix team environment.
Strong analytical and problem solving skills.
Ability to lead a team of multi-facility and multi-function employees to a successful
Strong communication and leadership skills.
Strong interpersonal, communication, influencing, and negotiation skills
Strong computer skills, excellent writing, organization, and presentation skills.
Living our leadership behaviors is a basic expectation for all Shire employees. Shire
expects all employees to embody the following:
Be An Excellent Manager of Self and Others
Complexity and Problem Solving
Responsible for providing strategic regulatory guidance and timelines to establish key objectives for
products. Ability to integrate regulatory strategy into overall product timelines. Responsibility for providing
Internal and External Contacts
Significant coordination with cross-functional teams internally and regulatory authorities externally, as
Other Job Requirements
Must be able to travel (approx. 10%), if needed.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.