Regulatory Product License Support Lead (Assoc. Director) -

Shire

Regulatory

July 31, 2014

Primary Role
The Product License Support (PLS) Lead is a team leader with first line accountability for GRO-managed submissions and regulatory information requirements for global health authorities. This role is responsible for setting the vision for assigned team and collaborating with GRO leadership to set goals, drive process efficiencies and overall operational effectiveness for regulatory submissions. The PLS Lead also plays a key role in user requirements gathering and GRA special initiatives.

Responsibilities
40%Direct GRO-managed Submission Management Activities:
 * Direct the activity for the GRO-managed submissions portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions.
 * Oversee the global tracking of GRO-managed submission timelines and communicating the submission forecast across GRA
 * Ensure staff is delivering high quality submissions to global regulatory health authorities within agency-required timelines, which are aligned to both Shire and health authority standards
 * Direct activities for non-submission regulatory reporting on behalf of GRA, ensuring GRO is managing data according to agency requirements and internal processes (e.g. Pharmacovigilance Safety Master File, XEVMPD, Drug Establishment Information).
 * Oversee vendor management and internal processes for Structured Product Labeling, ensuring Shire is communicating effectively with the vendor.
 * Lead staff with interpretation of global regulatory guidelines and approve processes, procedures and submission templates to ensure compliance with internal/external requirements.
 * Collaborate with leadership in GRO, GRA and R&D contributing groups to understand the global regulatory environment for Shire products and develop appropriate action plans for GRO.
 * Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring GRO staff.
 * Effectively forecast and manage project specific resources in a matrix environment, utilizing flexible resourcing and global work sharing as needed.

40% Drive Operational Effectiveness:
 * Ensure staff adherence to the appropriate use of technical tools to ensure regulatory and internal compliance is preserved.
 * Define and implement standards and process efficiencies for submission publishing and design effective change-management communications.
 * Write, review and/or approve process documentation, including SOPs and Policy documents.
 * Collaborate with GRO leadership to develop departmental performance goals/KPIs and monitor progress regularly.
 * Oversee the continuous improvement, development and integrity of GRO systems and procedures.
 * Suport legal requests, product divestments and related entities.
 * Support expansion of business and related integration activities.
 * Forecast and manage to the Submissions Management budget.
 * Provide Subject Matter Expertise for technical publishing tools.
 * Lead and/or represent GRO in GRA special initiatives.

20% Manage GRO Submissions Staff:
 * Mentor employees/consultants.
 * Interview, hire and train employees/consultants.
 * Manage direct reports' performance by setting clear objectives and development goals, providing frequent feedback and conducting performance assessments.

Education and Experience Requirements
 * Bachelor's degree is required. Scientific and/or computer science field preferred
 * Minimum 8 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.).
 * 5+ years of project management experience.
 * 3-5 years of line management experience.

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.

Application URL: http://www.aplitrak.com/?adid=andoYWxlbi44NzY1My4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

Apply Now

  • Company Shire
  • Contact Name Human Resources
  • Position Location Wayne County, Pennsylvania
  • Job Reference Code 8239BR
« Back to list

StratAcuity


 

Fresenius Medical Care