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Job Details

Regulatory Manager - Galavani Bioelectronics - Fremont, CA

GlaxoSmithKline
Fremont, CA
View GlaxoSmithKline Company Profile

Description

Basic qualifications:
• Bachelor degree or preferably PhD in biological or healthcare science
• Experience of all phases of the drug development process in regulatory affairs,
• Capable of leading regional development, submission and approval activities in local region(s)
• Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
• Knowledge of relevant area of medicine, and ability to further develop necessary specialist knowledge for the product or area of medicine


Preferred qualifications:
As above


Details:
Bioelectronic medicine is an emerging scientific field, aiming to use tiny implantable devices to change precise electrical signals in nerves to treat a range of debilitating chronic diseases. Galvani Bioelectronics represents an important step change in the research and development of these medicines, combining GSK’s discovery and development expertise and deep understanding of disease biology with Verily’s world leading expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications.

At Galvani Bioelectronics, we have demonstrated the feasibility of major inflammatory, metabolic, and respiratory diseases using neuromodulation of peripheral nerves in small animals. We have convincing reason to believe that these therapies, once proven through clinical studies, will bring a new therapy modality and help reduce the prevalence of major chronic diseases. Our ambition is to help patients, and through the development of efficacious therapies, become one of the world’s largest neuromodulation companies.

To provide EU/EMAP Regional support for the regulatory activities for Galvani Bioelectronics. Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal Galvani Bioelectronics process / policy and with regional regulatory requirements to deliver the best possible labelling, commensurate with the available data.

Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal Galvani process / policy and with regional regulatory requirements to deliver the best possible labelling, commensurate with the available data.

Responsibilities and Accountabilities (include expected deliverables, managerial and leadership responsibilities and performance standards)

Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within Galvani to VP level and representing GSK/Galvani with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for:

• Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally
• Implementation of the regional strategy(s) in support of the project globally
• Lead regulatory interactions and the review processes in local region
• Ensuring appropriate interaction with regional commercial teams in local region
• Ensuring compliance with regional requirements at all stages of product life from C2MD

Competencies and Capabilities (include key high performance behaviors)

• Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion
• Ability to foster strong matrix working. Involves people in issues that affect them. Facilitates dialogue between team and matrix members so they understand links between their different ideas and perspectives. Brings team members into the discussion so they can contribute their ideas. Capable of developing and recommending strategies for change. Developing personal networks, within Galvani and capable of using them to secure appropriate support and outcome for a project.
• Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises potential long term issues for projects.
• Ability to take sound decisions in doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions.
• Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process

Application deadline: 26th September 2017


Contact information:
You may apply for this position online by selecting the Apply now button.

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Details:

  • JobId: WD138513
  • Position Type: Full-Time
  • Experience Level: Not Specified
  • Posted / Updated: 9/13/2017

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