Manager Regulatory Affairs

Job Description :

Work Schedule

Environmental Conditions

Summarized Purpose:
Manages a team within the department and provides innovative solutions including regulatory expertiseand client interface to provide strategic regulatory intelligence and guidance for product developmentfrom preclinical through registration and product optimization.

Essential Functions:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management,behavioral and technical coaching and mentoring, employee counseling, andseparations. Approves courses of action on salary administration, hiring,corrective action, and terminations. Reviews and approves time records, expensereports, requests for leave, and overtime. Assures departmentadherence to good ethical and regulatory standards.

• Acts as subject matter expert in providing regulatory strategy advice and

• technical expertise to internal and external clients manages the coordination ofand ensures quality performance for key client projects. Manages and reviewsproject budgeting/ forecasting. Participates in and/or leads project meetings.

• Finalizes and reviews regulatory documents and submissions.

• Identifies and recognizes out of scope activities in a contract in a timely mannerand liaises with other departments to follow through on all aspects of contract modification.

• Collaborates with business development in pricing and securing new business bymaking presentations to clients and developing proposal texts and budgets incollaboration with other departments.

• Provides staff with up-to-date legislation and guidance as it becomes available.

• Ensures compliance with relevant organizational and departmental SOPs and WPDs.

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to8+ years).
2 + year of leadership responsibility

Knowledge, Skills and Abilities:

• Strong English language communication and negotiation skills, as well as local language whereapplicable, both oral and written

• Solid understanding of global/regional/national country requirements and regulatory affairsprocedures for clinical trial authorization, licensing and lifecycle management

• Thorough understanding of ICH and other global regulatory guidelines

• In-depth knowledge of at least one of the regulatory speciality areas: preclinical, clinical, CMC,publishing, etc.

• Strong understanding of budgeting and forecasting with the ability to interpret data with attention todetail and analytical and investigative skills

• Capable of supervising, evaluating, and mentoring departmental personnel

• Capable of delegating tasks and facilitating the completion of assignments

• Capable of driving innovation in developing new ideas related to process improvements

• Strong organizational, judgment, analytical, decision-making and interpersonal skills to managecomplex projects in parallel and manage rapidly changing priorities. Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.

• Capable of independently assessing sponsor needs and working with project team members inproducing compliant deliverables

• Capable of independently learning new technologies