Shire Regulatory Affairs CMC Lead in Lexington, Massachusetts

The Associate Director of CMC Regulatory Affairs will serve as the global product leader for CMC regulatory strategy of one or more biological and/or small molecule products. This will include formulating and implementing global CMC regulatory strategies for the development of protein therapies, lead CMC regulatory activities for assigned projects in line with global requirements. Primary role includes:

  • Serve as a liaison between the regulatory authorities and the company on CMC issues, with guidance from Team Lead and GRT

  • Provide CMC RA leadership within GRA and on cross-functional CMC teams

  • Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations

Essential Functions

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, new development efforts, content message points, or other related activities, for commercial and/or development programs. (50%)

  • Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)

  • Lead other development 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 & Experience Requirements

  • B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field

  • At least 7 years of drug development/pharmaceutical industry experience (or equivalent) including significant strategic experience (5+ years) in CMC regulatory affairs (or equivalent) with a small molecule and/or biologics background.

  • Demonstrated leadership in regulatory strategy and experience in regulatory interactions

Key Skills and Competencies.

  • Excellent interpersonal, communication, analytical and managerial skills.

  • Demonstrated experience with global development, registration and post-approval submissions

  • Ability to work successfully with cross-functional teams and influence appropriate plans and actions.

  • Strong attention to detail, establishing priorities, scheduling and meeting deadlines.

  • Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.

  • Ability to work independently, take initiative and complete tasks to deadlines.

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, 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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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.