Regulatory Operations and Information Management, Senior Manager - Biosimilars

  • Warsaw, Poland
  • Full-time
  • Department: Regulatory
  • Region: EU+/Canada

Company Description

About Biogen

Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients. As a company, Biogen recognizes that cutting-edge science and medicines can change the course of devastating diseases.  Biogen’s development of advanced biologic biosimilars will bring medicine to those who need them most.

For more information please visit:  www.biogen.com/careers

Job Description

HOME BASED POSITION

 

Role Profile

The Regulatory Operations and Information Management Lead will be responsible for timely and quality submissions to global regulatory authorities for both major and Lifecyle management submissions. Subject Matter Expert (SME) in the technical submission requirements of global health authority submissions to achieve technical validation/ acceptance.  Monitors and provides notification of changes in requirements as well as assessing the impact of agency guidance updates relevant to technical aspects of submissions.  Drives innovative process change for improved efficiency across technical submission processes and requirements. This includes the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Regulatory Operations and Information Management Lead collaborates on deliverable timelines with regulatory strategists, product leads and publishers while ensuring appropriate standards and expectations of quality. Influences stakeholders to ensure deliverables are in line with technical standards, quality, and timelines.

Provides training and leadership to project teams on requirements and expectations during the authoring of documents bound for submission, orientating to the regulatory systems and processes for GxP document management. 

 

Principal Accountabilities

Deliverables:

·       Responsible for global electronic submissions and documents meeting regulatory agency and Biogen submission standards and technical requirements.

·       Quality control checks on electronic common technical (eCTD) components, final submissions, document formatting, hyperlinks and bookmarks, and ensure submissions adhere to local health authority guidelines.  Reviews final submission for technical quality before dispatch

·       Demonstrates expert knowledge of submission or technology-related Global Health authority guidelines/regulations (including IDMP) and is responsible for adhering to them.

·       Oversees publishing deliverables and vendor activities on a day-to-day basis to ensure successful execution of operational activities for assigned products.  Decide on activity prioritization for vendor

·       Act as the lead submission sciences GDM during major submission deliverables and partner with the Global Regulatory Lead (GRL) and Global Regulatory Planning project manager

·       Provide submission status updates to all relevant stakeholders, including senior regulatory management and business leaders from other functions.

Process:

·       Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement associated process improvements.

·       Internal influencing, socializing and communication of changes.

·       Driver of quality of submission build, set submission standards and ensure vendor compliance with standards.

·       Responsible for understanding and communicating impact of Industry / Agency changes relevant to submission sciences and partnering with Biogen Innovator submission sciences team to ensure an aligned position.  Responsible for leading the vendor(s) and for driving identified innovative process change for improved efficiency.

Tracking:

·       Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets.

·       In addition to deliverable responsibilities, for major filings, the operations and information management lead will collaborate with BBU regulatory leadership and Biogen Innovator submission sciences team to lead assigned projects with manageable risks and resource requirements.

Subject Matter Expertise:

·       Maintain current regulatory knowledge and keep abreast of regulatory procedures and changes related to the electronic Common Technical Document.

·       Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH/global eSubmission regulations.

Collaboration:

·       Driving change, responsibility for a wide range of initiatives / relationships, as well as process efficiency / improvements. Acts as a liaison between members of submissions and other functional areas in order to ensure timely submission of regulatory-compliant, quality documents.

·       Assist functional leadership to analyse and assess performance of vendor-related activities against defined targets (e.g. collect and measure KPIs, performance metrics data). Driving new concepts for analysing data / promoting awareness of Regulatory Information Management strategies.

·       Provides training and leadership to project teams on requirements and expectations during the authoring of documents bound for submission.  Identify and assess impact of changing global submission HA requirements and provide education within authoring community.

·       Acts as lead business process SME for applicable regulatory systems orientating project teams to the regulatory systems and processes for GxP document management.

Qualifications

Education:

·     BS degree in life sciences preferable, IT/ Business acceptable.   Project Management qualification preferable

 

Qualifications / Skills:

·       6 to 8+ years pharmaceutical/ biotechnology industry with 4 to 6+ years regulatory operations experience

·       SME in eCTD

·       SME in regulatory operations processes

·       Good knowledge of applicable regulations, and submission standards/ requirements.  Ability to interpret regulations and guidelines.

·       Strong communication and project management abilities in global and virtual teams

·       Strong interpersonal skills and the ability to collaborate effectively across project teams, Biogen’s innovator business and with vendors.

·       Competent in the use of electronic document management and submissions publishing tools.

·       Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected.

·       Demonstrate strong organizational skills, including the ability to prioritize personal workload and to manage a large volume of complex tasks.

 

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
 

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