Manager - Regulatory Affairs

Primary Job Function:

With Manager Support:-

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

2. 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

3. Affiliate Coordination

Maintains strong working relationships with Regional Product Leads and Affiliate colleagues

4. 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

5. Strategy

Develops Regulatory CMC strategies for assigned products and projects

Identifies, communicates, and mitigates Regulatory CMC risks

6. Process Improvement

Identifies opportunities and suggests improvements

Supports the development of position papers & work aids etc

7. Health Agency Interaction

Attends Health Agency meetings as appropriate

8. Licensing Reviews

Provides CMC Regulatory support for due diligence activities

9. 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

Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary

Reacts quickly to solve problems and issues when they arise

Initiative

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

Innovation

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

Integrity

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.

Teamwork

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

LEADERSHIP COMPETENCIES

Set Vision and Strategy

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

Build Organization and Inspire People

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

Drive Results

Encourages others to complete goals

Make Difficult Decisions

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

Encourage an Open Environment and Knowledge Sharing

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