Manager Regulatory Affairs, CMC Biosimilar

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 biosimilar/ biologics 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

A minimum of 10 years of experience in Biosimilar Global Regulatory Affairs. Proven exposure to US and EU regulatory environment. Experience in emerging markets/ rest of world will be considered an added advantage.