Shire Regulatory CMC Manager - Plasma Network Strategy in 1445 Lawrence, California

Primary Duties

  • 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

Responsibilities:

  • 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:

Leadership Behaviors

  • Be Positive

  • Be Accountable

  • Be Results-oriented

  • Be An Excellent Manager of Self and Others

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.