GRA CMC Manager

Bern - Switzerland

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

We are looking for a

GRA CMC Managerto lead strategic and operational CMC regulatory activities across product development clinical submissions registrations and lifecycle this role you will shape global CMC regulatory strategy ensure compliant execution of submissions and changes and partner with technical and regulatory teams worldwide.

Key Responsibilities:

Drive global CMC strategies for clinical trial applications new product licenses and post-approval changes.

Assess CMC facility/equipment and plasma-related changes and manage regulatory submissions in coordination with regional teams.

Serve asprimaryregulatory liaison with technical experts; support GMP inspections and inspection readiness.

Interpret regulatory guidelines and requirements; prepare impact assessments and contribute to process improvements.

Providetechnical guidance to CMCScientists;may deputize for the CMC Team Lead.

Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates including as applicable:

Maintenance of the content of relevant parts of the regulatory dossiers.

Preparation revision and review of Module 2.3 Module 3 required facility and equipment information and related documents for new product registrations (e.g.MAAs BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation.

Timely provision ofhigh qualityresponses to CMC related Health Authority questions.

Compilation and review of CMC information for CTAs INDs and other regulatory submissions related to product development (e.g.CMC documentation for Scientific Advice Meetings Briefing Books IBs).

Provision or support oftimelyand compliant regulatory assessments as well as efficient execution of CMC changes.

Preparation and review of CMC related information and documentationfor tenders PSURs DSURs CCDS/productinformationand promotional materials.

Regulatory contribution to annual product quality reviews and risk assessments.

Responsible for strategic CMC regulatory activities related to the assigned products and/or intermediates including as applicable:

Is a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s).

MayrepresentGlobal Regulatory Affairs in Project Teams for CMC projects.

Is responsible fordevelopment and implementation of global CMC regulatory strategies for product development clinical trial applications new license applications productchangesand relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.

Is the primary GRA contact point interfacing with relevant technical expert departments for project planning purposescompilationand updates of technical documentation and for addressing CMC regulatoryquestions.

Evaluates the available technical and scientific CMC information for compliance with regulatory requirements performs gapanalysisand proposes solutions and strategies to remediate risks.

Supports scheduling and prioritization of CMC related submissions.

Qualification:

University degree in natural sciences (BS/BA/MS or equivalent) a degree in Regulatory Affairs isadvantageous.

Minimum of 5 years experience in the biotech or pharmaceutical industry with at least 3 years in Regulatory Affairs.

Sound knowledge in natural sciences with a focus on biological medicinal products.

Basic knowledge of the regulatory framework in at least one key region (US EU Japan CH Australia).

Competencies

Excellent communication project management planning problemsolvingand presentation skills.

Strong teamplayer with a demonstrated ability to develop constructive and effective relationships with peers and management.

Strong organizational and follow-up skills as well as attention to detail.

Ability to work with minimal supervision based on sound technical and analytical judgment.

Flexibility to work in a global cross-cultural work environment.

Microsoft Office skills.

Fluent in English and local language.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

About CSLPlasma

CSL Plasma operates one of the worlds largest and most sophisticated plasma collection networkswith over 350 plasma collection centers in the U.S. Europe and China. Headquartered in Boca Raton Florida CSL Plasma is a subsidiary ofCSL Behring a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent companyCSLheadquartered in Melbourne Australia employs 32000 people.

Learn more about CSL Plasma here and CSL CSL Behring CSL Seqirus and CSL Vifor here more about CSL CSL Behring CSL Seqirus and CSL Vifor here at and CSL Plasma at Benefits

For more information on CSL Plasma benefits visit Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Manager

We are looking for a GRA CMC Managerto lead strategic and operational CMC regulatory activities across product development clinical submissions registrations and lifecycle this role you will shape global CMC regulatory strategy ensure compliant execution of submissions and changes and partner with ...