Senior Regulatory Affairs Specialist Vacancy – Lonza

Senior Regulatory Affairs Specialist Vacancy – Lonza

Lonza Biochemistry Senior Regulatory Affairs Specialist Job. Biology job opening 2020. Biotech job opening 2020. Biology job opening. BS Biochemistry job opening 2020. Interested candidates may check out all the details on the same below:

Job Title: Senior Regulatory Affairs Specialist

Location: US – Portsmouth, NH

Job Description: 

Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist will support CMC project activities for customers and the Portsmouth site. Working collaboratively with company personnel, the Senior Regulatory Affairs Specialist will execute routine Regulatory Conformance activities (change controls, deviations, vendor change notifications), coordinate the regulatory CMC activities for development and commercial programs, provide regulatory support and advice for the Portsmouth site, and support the authoring of site-specific regulatory documents.

Key Responsibilities:

• Review change controls, deviations, and vendor change notifications for regulatory impact per established procedures
• Attend customer, department, and project team meetings
• Construct and maintain regulatory project plans in line with best practice recommendations
• Update functional leads and maintain transparency of information across regulatory function
• Maintain site manufacturing licenses, perform Establishment Registration and Product Listing as required
• Maintain the Portsmouth Site Master File per established procedures
• Support customer Rest of World submissions by providing required cGMP plant documentation
• Provide regulatory support and advice for external customers in line with defined Regulatory plans and in response to ad-hoc questions
• Write/review CMC sections and prepare briefing documents for agency meetings, as needed

Eligibility:

Senior Regulatory Affairs

• Bachelor’s Degree required, Masters preferred; preferred area of study, Chemistry, Biology, Biochemistry, Pharmacy or similar
• Working experience in the pharmaceutical industry, with experience in a Regulatory Affairs and/or preparing and authoring CMC sections for late-phase applications and license applications
• Understanding of biologics work processes.
• Ability to interpret compliance requirements for the creation or review of protocols and site documentation. .
• Proficient with Microsoft Office products
• Superb organizational skills and attention to detail
• Demonstrated ability to manage priorities and work under tight timelines
• Uses knowledge of their business area and related areas to make correct and timely decisions
• Able to work in a diverse environment to obtain solutions based on a solid background and understanding of the company procedures, regulatory guidance, current legislation and company objectives.
• Senior Regulatory Affairs Specialist Ability to review and critique complex technical documents.
• Strategic approach and system-oriented toward goals and objectives.
• Ability to represent the company on regulatory issues both internally and externally.
• Strong written and verbal communication; ability to present to various audiences’ levels.
• Able to communicate a site regulatory compliance philosophy internally and to clients.
• Fluent in English

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