Lonza
Senior Regulatory Affairs CMC Specialist
Lonza, Portsmouth, New Hampshire, United States, 00215
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Senior Regulatory Affairs CMC Specialist will support the site and customer related regulatory affairs and CMC project activities. This person will work collaboratively with company personnel to co-ordinate the regulatory work stream elements for RA CMC compliance and/or RA CMC writing and review activities for Lonza Biologics Manufacturing customers. The Sr. Specialist will also provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions.
Key Responsibilities:
Lead the preparation and/or review of scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures.
Inform customers of Lonza’s Regulatory process for dossier preparation and completion.
Lead the preparation and/or review of customer clinical (e.g IMPD/INDs) and contribute to commercial (e.g. MAA/BLAs) submissions.
Preparation and/or review of responses to agency submission review questions.
Preparation and review of customer variation submissions.
Preparation of documents to support customer scientific advice meetings and development of regulatory strategy with customers.
Prepare source documents (facility and equipment appendices) for customer RoW submissions including certifications and attestations where applicable.
Internal regulatory support for operation and control:
Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of Biological products.
Support site-specific regulatory documentation and activities.
Maintain transparency of information across regulatory function.
Support for site inspections and audits, improvement and development projects.
Perform Regulatory assessments for deviations and change controls.
Provide support for VCNs and other project team queries, as requested.
Maintenance of Lonza site Facility registrations with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA).
Creation and maintenance of Lonza Drug Master Files as appropriate for site activities.
Key Requirements:
Bachelor's degree preferred in Life Sciences field.
3+ years and significant related RA experience.
Familiarity with the CMC dossier, specifically modules 3.2.S, 3.2.P for biologics/MAB formulations.
Experience writing or drafting BLA/IND/IMPD applications to multiple health authorities (i.e. USFDA, EMA, China, Japan, rest of world).
Strong proficiency MS Office applications.
Strong written and verbal communication skills.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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The Senior Regulatory Affairs CMC Specialist will support the site and customer related regulatory affairs and CMC project activities. This person will work collaboratively with company personnel to co-ordinate the regulatory work stream elements for RA CMC compliance and/or RA CMC writing and review activities for Lonza Biologics Manufacturing customers. The Sr. Specialist will also provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions.
Key Responsibilities:
Lead the preparation and/or review of scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures.
Inform customers of Lonza’s Regulatory process for dossier preparation and completion.
Lead the preparation and/or review of customer clinical (e.g IMPD/INDs) and contribute to commercial (e.g. MAA/BLAs) submissions.
Preparation and/or review of responses to agency submission review questions.
Preparation and review of customer variation submissions.
Preparation of documents to support customer scientific advice meetings and development of regulatory strategy with customers.
Prepare source documents (facility and equipment appendices) for customer RoW submissions including certifications and attestations where applicable.
Internal regulatory support for operation and control:
Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of Biological products.
Support site-specific regulatory documentation and activities.
Maintain transparency of information across regulatory function.
Support for site inspections and audits, improvement and development projects.
Perform Regulatory assessments for deviations and change controls.
Provide support for VCNs and other project team queries, as requested.
Maintenance of Lonza site Facility registrations with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA).
Creation and maintenance of Lonza Drug Master Files as appropriate for site activities.
Key Requirements:
Bachelor's degree preferred in Life Sciences field.
3+ years and significant related RA experience.
Familiarity with the CMC dossier, specifically modules 3.2.S, 3.2.P for biologics/MAB formulations.
Experience writing or drafting BLA/IND/IMPD applications to multiple health authorities (i.e. USFDA, EMA, China, Japan, rest of world).
Strong proficiency MS Office applications.
Strong written and verbal communication skills.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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