Description:
Title: Regulatory Affairs Scientist - CMC

Location: M4 Corridor, UK

Schedule: Full-time

CROMSOURCE is looking for an experience Regulatory Affairs Scientist to join one of our biotechnology partner companies in the UK. The Regulatory Affairs Scientist will be responsible for supporting Regulatory CMC for all new chemical entity products within the scope of the Neurology, Immunology and Bone therapeutic areas. This will encompass providing support/leading regulatory CMC submissions for all products within the scope.

This opportunity is open to both employees and freelance applicants.

The successful candidate will be working on studies dedicated to one client. We are looking for someone with strong project management skills with Phase I studies, who is able to act quickly, make well considered decisions and provide solutions.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Main Responsibilities and Accountabilities:

• Support for developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
• Identify supporting documents required for regional submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
• Write regional and global CMC documentation for submissions, in line with agreed global regulatory strategy, and within agreed timelines.
• Highlights anticipated and ongoing critical issues arising through the product life-cycle in a timely manner to enable communication to key stakeholders as appropriate.
• Contribute to the preparation of the CMC SWOT analysis (or regulatory Risk Capture Document) and supports associated CMC challenge sessions.
• Lead or provide support to all CMC related interactions to facilitate and ensure satisfactory resolution of CMC issues and negotiates CMC approvals with Health Authorities in regions assigned for assigned projects/products.
• Support cross-functional teams responsible for the preparation of responses to Health Authorities CMC questions raised.
• Monitor and respond as appropriate to changes in the CMC regulatory environment to support and advice.
• Establish and maintain modes for effective communication and collaboration with the wider team members.
• Provide regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, UPILOT etc.) for assigned regions within defined timelines.
• Lead or provide input to internal regulatory business initiatives and cross functional work streams as assigned.

Education, Qualifications & Experience:

• Bachelor's Degree in Life Sciences or equivalent. Master's or PhD is preferred.
• Extensive level of relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity.
• Must have proven experience in a Regulatory Affairs CMC Biotech function as well as experience in pharmaceutical manufacturing, analytical development and quality assurance/control or related technical field.
• Proven track record of successfully authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products.
• Experience of direct communication and negotiation with regulatory agencies on CMC matters
• Experience participating in regulatory agency meetings on CMC matters

Skills & Knowledge:

• Ability to contribute to globally diverse teams, meetings and discussions to deliver CMC sections of regulatory submissions for development and post-approval products
• Global mind-set when defining regional CMC regulatory strategies and able to plan/coordinate delivery of related tasks and objectives
• Experience negotiating and influencing others to deliver strategic business and CMC priorities in assigned regions
• Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
• Effectively works to build relationships and collaborate with people and teams
• Good communication skills
• Ability to work cross-functionally, in a matrix organisation structure
• Can negotiate and influence others to deliver strategies with a global mind set.

Why TalentSource Life Sciences/CROMSOURCE?

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters location is in Verona Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and regarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

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Keywords: Regulatory Affairs, Reg Affairs, Scientist, Regulatory Scientist, Regulatory Associate, CMC, Chemistry Manufacturing Control, Regulatory Specialist, Biotech, Biotechnology, RA, Contract Research Organisation, CRO, Outsourced
Skills: CMC Manager, CMC Location: United Kingdom Share:

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