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Senior Regulatory Affairs Associate - Vaccine and Medical devices.

The Company
Our client partnered with KE Select to find their new Senior Regulatory Affairs Associate. If you want the opportunity to work with a leader in Vaccine technology, they will be one of the best places to work with in the coming years.

The Role
As a Senior RA associate, you will work within the Clinical and Regulatory team. The main core of the role will be to prepare, manage and submit of regulatory applications to global health authorities. Responsible to liaise with internal and external stakeholders, you will provide regulatory guidance to all team and mentor some junior staff.

Major Responsibilities
    • Regulatory applications for submission to FDA, EMA, TGA and other regulatory authorities as required. Build and maintain strong working relationships with regulatory authorities.
    • Act as the regulatory point of contact for specific projects.
    • Work closely with subject matter experts in all departments to ensure content of regulatory applications are accurate.
    • Understand and be able to communicate to team members and other stakeholders the current international regulatory requirements for the products.
    • Support collaborators to ensure all regulatory documentation is provided in accordance with collaborator timelines.
    • Develop and execute optimal regulatory strategies to support business needs.
    • Maintain knowledge of applicable regulatory affairs intelligence including regulatory guidelines, competitor landscape and changes to regulatory processes which may impact the business.
    • Managing the project budget and scope.

Required Skills/Experience/Education
    • Previous experience with vaccines would be highly regarded.
    • At least 5+ years’ experience in regulatory affairs, working in a biotechnology, pharmaceutical or medical device company.
    • Ability to work independently and to manage work priorities to meet competing deadlines.
    • You must have a self starter attitude, be flexible and be adaptable to the ever-changing timelines and project priorities.
    • Expert knowledge of the drug development process, local and international regulatory requirements for a combination product.
    • Excellent interpersonal, communication and team management skills.
    • Possess excellent risk management and problem-solving skills.
The company is offering a good package including Base + Superannuation. Our client is also going through an exceptional growth. The potential for the candidate is exceptional with some exciting time ahead.

How to apply
We are currently short-listing candidates so if you are interested in this role, please click on APPLY now and submit your application. Alternatively, you can contact Christelle at KE Select on 0401 691 247.

KE Select is an Australian-based, leading Scientific & Medical Recruitment Partner for many organisations within the Life Science, Medical, Clinical, Hospital and Healthcare space.

We Specialise in Permanent and Temporary​ recruitment across Australia and New Zealand. If you are a candidate looking for a new role or a company looking for industry-specific recruitment firm, please visit our website to find out more. www.keselect.com
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