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Shire Regulatory CMC Manager - Plasma Network Strategy in 1445 Lawrence, California
The CMC Regulatory Affairs Manager will provide leadership and be the Regulatory CMC point of contact for major changes to the supply network for plasma products, including but not limited to, site-to-site technical transfers, QC transfers, changes to external network, and internalization. This will include formulating and implementing CMC regulatory strategies, lead CMC regulatory activities for assigned projects in line with US or ICH requirements, using contemporary submission standards, and owning all aspects of Modules 2.3/3.
Primary role includes:
Serve as a liaison between the network project teams and the GRA CMC Product Lead
Provide CMC RA leadership within RA and on cross-functional CMC teams
Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations
Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls (10%)
Provide CMC regulatory strategy for proposed changes or other related activities for commercial programs. (50%)
Facilitate timely regulatory approvals by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)
Lead other functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)
Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)
Education and Experience Requirements
B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
Minimum of 7 years of strategic experience in CMC regulatory affairs, or equivalent, 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 and timelines 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:
Be An Excellent Manager of Self and Others
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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.