Regulatory Affairs CMC Lead

Regulatory Affairs CMC Lead

Job Introduction

CMC Lead who has CMC (Chemistry, Manufacturing and Controls) and manufacturing compliance responsibility for assigned products for Europe and LAM regions.   This includes provision of CMC strategic guidance and advice to Project Teams and managing CMC and manufacturing compliance risk across projects.
Ensures the performance and quality delivery from internal and external CMC team members and is a point of escalation for CMC and manufacturing compliance challenges and risks.
May be the Process Owner for CMC Activities and drives process excellence and optimisation for CMC.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

CMC Lead:
Co-Lead the CMC group and ensure a high quality, value added CMC service to customer groups
Customer focused (Supply Chain, IAC’s), engaging positively with stakeholders and customers to add value to the organisation
Build and maintain relationships with all departments, and network with other functions to ensure effective communication and efficient implementation of CMC activities
Act as Senior CMC Expert, lead CMC strategy, provide CMC advice to and work in collaboration with RA leaders, Supply Chain, Technical Development, IAC’s and external partners
Evaluate the impact of new regulations on the Mundipharma business and undertake appropriate action including communication within DSRA and with appropriate stakeholders and customers
Provide expert scientific CMC advice on items or issues which affect the company/products.   
Develop appropriate CMC strategies and messaging for successful engagement with Health Authorities.
Provide risk identification and risk mitigation strategies for CMC to Senior Management, stakeholders and customers when appropriate
Take a high level of personal responsibility and accountability for managing and delivering complex CMC projects, for problem solving, and business critical decisions
Ensure quality CMC regulatory documents are generated within the matrix team (internal and external resources).  Responsible for the review and approval of CMC documents such that they are of high quality and align with agreed strategy
Ensure all CMC documents are properly managed and tracked in relevant systems and databases
May lead RAST teams when appropriate
Provide due diligence support for CMC reporting to Senior Management to tight timelines
Ensure CMC team own the manufacturing compliance for their products, keeping appropriate records and documentation up to date
Process Owner:
Act as Process Owner for CMC activities, overseeing delivery from the team, ensuring quality, timely delivery of all activities from both internal and external resources.
Ensure appropriate process capture and lead process improvement for CMC.  This will require focus on process detail whilst also balancing the interconnectivity of the CMC processes across Mundipharma, Supply Chain and external stakeholders.  Lead appropriate change management activities as required
Engage with stakeholders to drive process and communications improvements leading to improved, measurable performance efficiency across the organisation
Project manage and lead CMC tasks, which may have a high degree of impact to the business
Working with Quality Management and the Process Excellence and Metrics Lead to develop and maintain the KPI system for all CMC activities

Work collaboratively with other CMC Lead to ensure alignment and consistency of knowledge, experience and process
People Management:
Lead, line manage and mentor a CMC team
Ensure appropriate training and development of staff. Evaluate performance of CMC team members on an ongoing basis and take appropriate steps to develop the team.
Manage under-performance actively.
Has full management authority for their team members, including performance reviews
Act as role model for the Company values and leadership attributes, in particular demonstrating vision and strategic focus, being inspirational, awareness of bigger picture, flexibility.

Attends and participates in appropriate learning events for both personal and professional development.  Brings learnings back and shares these proactively with the team.

Key Competencies

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Main requirements

Knowledge & Experience
Significant experience working in pharmaceutical industry, CMC, pre-approval, post approval and product technical development. Relevant experience in regions such as EU, MEA, LATAM and APAC.
Significant experience in determining CMC strategy and successfully proposing this to stakeholders and customers.  Ability to interpret HA queries and guidelines to support strategy generation
Significant experience in managing and mitigating CMC risk. 
Experience in engaging with Health Authorities and generating appropriate CMC messaging for all interactions (either via written documentation/submissions or during meetings)
In-depth knowledge of technical and scientific information, legislation and relevant Regulatory Guidelines and can assess their impact on the business.
Possesses excellent written and oral communication skills.
Thorough understanding of data management systems and international CMC requirements
Experience interfacing with local regulatory subsidiaries and working on regulatory submissions
Experience working with contract manufacturing organisations with knowledge of Manufacturing processes and Technical Drug Development.
Experience working in a fast paced high growth virtual environment, across functions and cultures
Experience of managing and developing a high performing team
Broad range of people leadership experience to deliver strategic results
Evidence of developing the talent of others and the ability to mentor Cultural awareness gained from international experience
Personal & Leadership Characteristics
Dynamic, nimble, proactive and self motivated
Demonstrates drive, a “can-do” attitude and is committed to delivering results
Proven ability to lead teams in a matrix environment
Ability to effectively manage internal and external relationships
Ability to work effectively through large diverse skilled teams to achieve results
A strategic thinker who can develop effective CMC strategies and messages for engagement internally and externally
Excellent interpersonal and professional skills to interact at all levels including senior executives, contractors, and colleagues
Risk Management and mitigation skills
Problem Solving skills and ability to manage and implement changes
Highly organised, with good time management and prioritisation
Critical thinking/ evaluation of process problems
Strong work ethic 
Looks beyond own discipline knowledge and uses sound judgement to resolve complex problems
Leadership skills with both practical and long term strategic vision
Ability to build relationships and inspire confidence and respect at all levels
Strong team player with effective delegation skills
Able to build rapport and demonstrate influencing and negotiation skills
Strong communication and listening skills - receptive to feedback and demonstrating flexibility and empathy
Business curious, demonstrates adaptability, curiosity and an ability to learn
Supports and encourages ownership and responsibility
Strives for continuous improvement
Thinks analytically with the ability to see the bigger picture
Has courage to make business and people management decisions
Consistently demonstrates and encourages others to embrace the Company’s Core Values; Honesty, Respect, Passion, Innovation and Commitment.
Strong ethical standards and a high level of personal integrity.
Adheres to the Company’s Compliance and Code of Business Ethics guidelines.

Contact Information

Name: Louisa Hodgson
Email: mr.hr@mundipharma-rd.eu
Telephone: 01223 424900
Adress: Mundipharma Research Limited
Unit 196 Cambridge Science Park
Milton Road
Cambridge C4 0GW

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