Manager - Regulatory Affairs

Primary Job Function:

1. Product registrations / Submissions

• Actively leads product registrations by preparing/ requesting documentation needed for complex filings
• Employs project management skills to monitor activities and meet deadlines
• Prepares registration packages for routine filings
• Identifies and collects data needed
• Seeks expert advice and technical support for complex filings
• Prepares responses to deficiency letters

1. Relationships & Cross Functional team work

• Represents Regulatory CMC at relevant project meetings and communicates agreed RA position
• Monitors and communicates actual versus planned regulatory activities and timelines
• Identifies and communicates risks and issues impacting project progression

1. Affiliate Coordination

• Maintains strong working relationships with Regional Product Leads and Affiliate colleagues

1. Compliance across Life-Cycle

• Assesses and approves change requests and updates files accordingly
• Maintains awareness of legislation and current developments within specific area of business
• Works to assure products remain in compliance

1. Strategy

• Develops Regulatory CMC strategies for assigned products and projects
• Identifies, communicates, and mitigates Regulatory CMC risks

1. Process Improvement

• Identifies opportunities and suggests improvements
• Supports the development of position papers & work aids etc

1. Health Agency Interaction

• Attends Health Agency meetings as appropriate

1. Licensing Reviews

• Provides CMC Regulatory support for due diligence activities

1. Technical competency

• Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products
• Has general knowledge of global and regional regulatory requirements

-Has specialist regulatory knowledge of assigned country or product-class requirements

CORE COMPETENCIES

Adaptability

-Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks

• Reacts quickly to solve problems and issues when they arise

• Starts to learn new aspects of the business and understand the roles of other functions
• Proactively anticipates, mitigates and avoids problems and issues
• Proactively seeks feedback from manager and team members and adapts behaviour to improve performance

• Has an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities

• Delivers high quality results.
• Meets agreed deadlines.
• Exhibits honesty and presents complete impartial information.
• Displays consistency between words and actions.
• Acknowledges and responds constructively to failures and mistakes.

-Expresses dissatisfaction constructively, without over-reacting.

• Actively interacts with colleagues to drive completion of team and shared goals

LEADERSHIP COMPETENCIES

• Clearly articulates Regulatory CMC strategies and obtains alignment and agreement from key stakeholders

• Mentors junior team members
• Provides training and support on areas of subject matter expertise
• Proactively strengthens own leadership skills and actively uses these skills in day to day work

• Encourages others to complete goals

Make Difficult Decisions

-Interacts with cross-functional and department colleagues to help drive efficient decision-making

• Provides honest, accurate feedback to managers, whether positive or negative
• Not afraid to challenge peers and managers and be challenged
• Openly shares information with peers

Minimum Education:

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

Minimum Experience/Training Required:

A minimum of 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas