Description:
Title: Regulatory Affairs CMC Scientist

Location: South-East England

Schedule: Full-time

CROMSOURCE is looking for a Regulatory Affairs CMC Scientist to join one of our partner companies - an international biotechnology company, based in the South East of the United Kingdom.

The successful candidate will be working on studies dedicated to one client.

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:

• Raise potential and ongoing critical issues through the product life-cycle in a timely manner to ensure communication to key stakeholders.
• Provide contribution to the preparation of the CMC SWOT analysis and support the associated Regulatory Affairs CMC challenge session.
• Lead or provide support to all CMC related interactions to facilitate and ensure satisfactory resolution of CMC issues.
• Negotiate CMC approvals with Health Authorities in regions and projects/products assigned.
• Support cross-functional teams responsible for the preparation of responses to the Health Authorities CMC questions.
• Keep track of changes in the CMC regulatory environment in regions assigned.
• Provide regulatory affairs CMC input to the Technical Operations team.
• Act as regulatory CMC representative on the Regulatory Affairs Practice Teams and Submission Strategy Teams
• Provide regulatory assessments for CMC changes and creation of entries and updates in the designated systems for assigned regions within defined timelines.
• Develop and implementing the regional CMC regulatory strategy and submission plans for assigned projects and products to deliver timely approvals
• Identify supporting documents required for regional submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.

Education

• Bachelor's Degree in Life Sciences or equivalent. Master's or PhD is preferred.

Minimum Work Experience

• Previous experience working within Regulatory Affairs CMC within the CRO or Pharmaceutical industry is required.

Skills

• Excellent interpersonal and relationship building skills.
• Strong verbal and written communication skills including excellent presentation skills.
• Client focused approach to work
• A flexible and adaptable attitude with respect to work assignments
• Results focused approach
• Good analytical skills
• Ability to manage multiple and varied tasks with enthusiasm and prioritise workload with attention to detail.
• Value the importance of teamwork.
• IT literate.
• Sense of urgency in completing assigned tasks.

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.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Keywords: Regulatory Affairs, Reg Affairs, RA, Scientist, CMC, Biologics, Biotech, Biotechnology, Biopharmaceuticals, Biopharma, Contract Research Organisation, CRO, Outsourced, Pharmaco, Pharmaceutical, Inflammatory Disease
Skills: Regulatory Affairs Associate, Regulatory Location: United Kingdom Share:

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