Manager, Regulatory Affairs



August 23, 2014

Primary Duties
Responsible for the management of US regional regulatory activities for assigned development and commercially marketed products in the US. The major roles and responsibilities of this position are:

* Responsibility for corporate liaison with FDA and other national regulatory agencies as appropriate;
* Responsible for the development, content and submission of complete and quality regulatory filings;
* Responsible for the provision and execution of effective and optimal regional regulatory strategies;
* Management, development and mentoring of assigned regulatory staff.

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 compliance with national regulatory standards and commitments.

* Act as primary FDA agency liaison contact for defined product(s).
* Develop and implement internal and external strategies to proactively influence 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 regional regulatory technical and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in US. Represent GRA at commercial, development or clinical operational sub-meetings of regional focus.
* Ensure effective development and execution of optimal strategies for development programs for defined products.

* Responsible for complete and quality regional specific technical documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements. Accountable for overall content and management of regional filings i.e. NDA/BLAs, INDs, etc.
* Responsible for overall strategy and content for local label development. Collaborates with Global Regulatory Labeling team to ensure alignment with CCDS. Sets quality and accuracy standards for regional regulatory technical documentation. Responsible for regional project/timeline planning input.
* Accountable for ensuring regulatory compliance standards and regulatory commitments are met. Management of regulatory master files and liaison for local FDA (nonclinical and clinical) inspections.

* Actively participate as member of Global Regulatory Teams supporting products.
* Collaborate with key internal partners (e.g. GRLs, CMC Leads and Operations) 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.

* Manage performance assessments, career and skill development activities of assigned staff members.
* Manage staff/contractor project assignments and workloads.
* Provide direction on workload prioritization and operational effectiveness.

Education and Experience Requirements
* Science degree in a biological science is required. Advanced degree (M.D., PhD, or Pharm.D.) preferred.
* Minimum of 10 years in drug/biologics development in the US pharmaceutical and biotechnology industry or Government Health Agency, with at least 3 years experience in a regulatory leadership role.
* Prior regulatory agency liaison experience is essential. Demonstrated track record of successful management of submissions and approvals to FDA is required.
* Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred.
* Prior supervisory experience is valuable.

Key Skills, Abilities, and Competencies
* Capable of managing multiple projects and complex timelines in a team environment
* Excellent interpersonal, communication, analytical and organizational skills. Good negotiation skills essential.
* Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
* Excellent staff management skills, ability to lead, train and mentor staff at all levels
* Ability to work in a highly matrix working environment is important given the need to interact effectively with other GRA functions, internal departments and external organizations.

Other Job Requirements
10-15% travel mostly within North America. Some international travel may be required. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Please apply at: Application URL:

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  • Company Shire
  • Contact Name Shire
  • Position Location Lexington, Massachusetts
  • Job Reference Code 8986BR
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