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Director Regulatory CMC - Biologics

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POST DATE 8/17/2016
END DATE 11/19/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Masters Degree


Job Description
Under the direction of the Senior Director of Regulatory Affairs, direct and manage Regulatory Affairs activities for developing and executing CMC strategies across product life cycles. Manage submissions and interactions with the FDA and other regulatory agencies for CMC issues.

Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs, and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they may be studied and marketed as planned. coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives.

Develop CMC regulatory strategy and manage regulatory activities and timelines for investigational and marketed products. (25%)
Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies. (25%)
Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to ensure conformance with regulations and existing regulatory approvals. (25%)
Provide CMC regulatory guidance to Project/Product teams. (25%)

M.S. / Ph/D. in biochemistry, chemistry, biology pharmacy, or related pharmaceutical field. Minimum of 7 years experience in pharmaceutical product development with a minimum of 4 to 5 years in leadership CMC regulatory affairs and a strong biologics background. Medical Device and/or Combination Product experience desirable. Significant experience in directing interactions with regulatory authorities. Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

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.

Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

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.

Minimum Requirements