Shire Regional Regulatory Strategist in Cambridge, Massachusetts

Primary Role:

Member of the Rare Disease Regulatory Strategy team responsible for assigned development and commercially marketed products in the US. The major roles and responsibilities of this position are:

i) Responsibility for corporate liaison with FDA and other national regulatory agencies as appropriate, and

ii) Responsible for the provision and implementation of effective and optimal regional regulatory strategies, and

iii) Responsible for the effective management and execution of regulatory filings.

Key accountabilities include developing effective professional relationships with regulatory agencies to ensure a positive company image, as well as providing technical and procedural regulatory guidance and strategy to key internal stakeholders to advance the development, commercialization and life cycle of Shire products.

Ensuring effective and timely execution of regulatory filings maintaining compliance with national regulatory standards and commitments.

Responsibilities:

40%:

Act as primary FDA agency liaison contact for defined product(s).

Ensure the development and execution of robust regulatory strategies which incorporate compliant regional technical and procedural legislation/guidance with impact on Shire business.

Provide regional input into Global Regulatory Strategic Plans for assigned products/programs.

Act as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US.

Represent GRA at meetings of regional focus.

30%:

Responsible for US specific technical documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.

Accountable for overall content and management of local regulatory components and filings i.e. NDA/BLAs, INDs. Responsible for overall strategy and content for local label development and alignment with CCDS.

Sets quality and accuracy standards for regional regulatory technical documentation. Responsible for regional project/timeline planning input.

Ensure regulatory compliance standards and regulatory commitments are met.

Management of regulatory master files and liaison for local Agency (nonclinical and clinical) inspections.

30%:

Actively participate as member of Global Regulatory Teams supporting products.

Collaborate with key internal GRA, R&D and commercial partners and other key stakeholders (e.g., VPs, customers, business leaders) to support a globally effective organization.

Apply influence and negotiation skills to drive business results and resolve issues.

Education & Experience Requirements:

• BA/B.S in a scientific, healthcare or related field or equivalent experience. Advanced degree preferred, but not required.

• Minimum of 8 years in drug/biologics development in the US pharmaceutical and biotechnology industry or Government Health Agency.

• Demonstrated track record of successful management of submissions in US regulatory affairs is required. Prior regulatory agency liaison experience is preferred.

• Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred.

Key Skills, Abilities, and Competencies

• Excellent communication skills both written and verbal

• Demonstrates strong ability to collaboratively interact and work effectively with other departments as well as external organizations

• Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines

• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions

About Shire:

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.

Equal Employment Opportunity

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 at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

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

Pay Transparency Policy at 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.

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.

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.