Shire Regulatory CMC Lead- Gattex/Revestive in Lexington, Massachusetts

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.

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

Describe the essential job duties. After each, provide an estimate of the percent of time typically devoted to each responsibility (use increments of 5%, all time spent should total to 100% of time allocation). To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.

• 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

Include educational requirements or equivalency, required years and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred.

• 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

Describe critical skills needed to successfully perform job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Primary Responsibilities include:

  • 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%)

Notice to Employment / Recruitment Agents:

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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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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.