CMC Process Development - Senior Manager

Geneva, Canton of Geneva (CH)
Salary
Dependent on experience
Start date
24 Apr 2020
Closing date
24 May 2020
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Discipline
Manufacturing
,
Process
,
Regulatory Affairs
,
CMC
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
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Job Details
Company

Job Details

Job Summary
Are you passionate about making a difference to patients’ lives? Do you want to build a strong career within a company that excels in delivering high quality research? Why not let our client realise your potential? Join one of the most successful, internationally recognised and established clinical teams in the industry.

Company Statement
Our client is one of the largest, most reputable clinical research orginisation who research, develop, manufacture and market their own products. They are a pioneer in leading edge research in drug trials and medical devices, they bring novel therapies to improve quality of patients’ lives around the world!

Responsibilities

• Oversee and be responsible for the responses to questions from regulatory authorities for Process Development in coordination with the appropriate expert
• Lead authoring, reviewing and editing of dossiers
• Make sure documents generated meet future submission regulations
• Drive best practice
• Ensure timely response to regulatory questions from Process Development
• Review information that is used to write sections of regulatory submissions
• Liaise with functional heads
• Build and sustain transparency with SMEs
• Develop and maintain scientific expertise in Biosimilars development

Qualifications

• Biologics experience is key for this position
• Biosimilars experience / knowledge would be a bonus
• Experience in a Biotech manufacturing environment
• Experience of both authoring and reviewing scientific documents
• Previous experience supporting submissions (US & EU experience highly desirable)
• Experience liaising with regulatory authorities / responsible for the responses to questions
• Flexible / adaptable; candidates must be used to all manner of activities and comfortable with changing priorities
• Extremely organised
• Strong interpersonal skills as will be working closely with other members of the team, and also liaising with Regulatory Affairs
• Self-awareness and awareness of the needs of the wider team

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.
Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info

Website
http://www.planet-pharma.co.uk/
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
GB
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