Manager - Regulatory Affairs

Job Description

Primary Job Function:

-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

-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

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

-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

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

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

-Attends Health Agency meetings as appropriate

-Provides CMC Regulatory support for due diligence activities

-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

-Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks
-Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary
-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

-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
Supervisory/Management Responsibilities:

Direct Reports: None (individual contributor)
Indirect Reports: None (individual contributor)

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