Job Description

THE POSITION:

• As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals.

• Provide strategic input into the development of assigned projects handling complex issues, seeking
• guidance where appropriate.
• Ensure input from cross functional team members and issues regional regulatory plans as appropriate.
• Attendance at project teams representing EPD RA as appropriate.
• Prepare regulatory filings for submission to regional regulatory agencies.
• Manage strategy for response to regulatory agency queries, ensuring scientific dossier content and consistency of scientific content and Company position across geographic areas.
• Develops, rewards and shares talent;
• Coordinate assigned affiliate(s) workload planning & prioritization and performance
• Monitor actual vs. planned activities and timelines.
• Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression
• Prepare and present written and oral reports and other presentations to team members and other internal audiences. Adjusts presentation style and content to suit the audience.
• Manage the preparation and review of technical strategic regulatory documentation for agency submission.
• Responsible for ensuring accuracy and quality of documentation.

• Works primarily with internal EPDRA contacts, Affiliate RA and Regional Counterparts (Commercial, Operations, QA, etc).

• Manage projects within assigned geographic area.
• Maintain geographic intelligence, liaison and affiliate support for specified countries as provided by
• manager
• Manager provides project assignments and strategic direction
• Minimal supervision of project required

• Accountable for assigned project/task scope; completion with scheduled completion date
• No direct budgetary responsibility
• Adheres to departmental guidelines on expenses
• Identifies opportunities for cost savings
• Provides estimates of activities with budgetary impact

• Maintains leadership presence and emotional control in difficult situations.
• Provides insight, knowledge and leadership to improve functional area and build the business

• Anticipate future problems, resolve current issues. Learns and adjusts based on prior results.

• Maintain awareness of new draft legislation and guidelines.
• Communicate impact and relevance of new draft legislation and guidelines to project teams
• and colleagues.

• Follows and communicates EPDRA positions and policies to project teams to ensure standard
• interpretation of regulations for defined project or task.

• Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject

• 3+ years in R&D or related area; ideally includes 5 years in Regulatory