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

sharepoint site.

 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

teams

o Maintain up-to-date knowledge and expertise of relevant FDA, ICH and local

country guidelines and regulations

Responsibilities

 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

pharmaceutical field

 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

outcome.

 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:

Leadership Behaviors

 Be Positive

 Be Accountable

 Be Results-oriented

 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

regulatory decisions.

Internal and External Contacts

Significant coordination with cross-functional teams internally and regulatory authorities externally, as

applicable.

Other Job Requirements

Must be able to travel (approx. 10%), if needed.

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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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.