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Head of Regulatory Affairs

Porton Biopharma
Pay: On Application
Job Type: Other/General
Location: Wiltshire Wiltshire United Kingdom
Category: Gap/Temp And Parttime/Holiday
Available from: Immediately
Finishes on: Ongoing Position
Type of work: Full Time , Daytime Work
Job reference: E03671595
Government 2021-01-23 2021-01-30

Job Description

An exciting opportunity has arisen for a Head of Regulatory Affairs to join Porton Biopharma, a leading biopharmaceuticals company located on the historic Porton Down site, in the picturesque countryside of Salisbury, Wiltshire.

Porton Biopharma Limited (PBL) is a limited liability company, established in 2015, to commercialise pharmaceutical development and manufacturing capabilities. Our mission is to protect patients' health through the quality-assured development and production of biopharmaceuticals. We develop new vaccines, therapeutic proteins and enzyme products, and manufacture our own licensed biopharmaceutical products, Erwinase® and the UK's Anthrax Vaccine.

We offer specialist expertise in the development of both manufacturing and analytical processes for use with biological pharmaceutical products. Particularly in taking concepts from the research laboratory and progressing them through the various stages of scale-up and process development to manufactured product for licensed supply or clinical trial.

Our employees join us safe in the knowledge that their skills and experience are contributing to a valuable purpose. This is an excellent environment for the right person to build their biopharmaceutical career.

The Head of Regulatory Affairs will be in receipt of a competitive benefits package, including:

* 30 days of holiday, plus 8 bank holidays;

* On the job training, and genuine opportunities for growth and advancement;

* Generous pension scheme;

* Access to online discounts;

* A work environment based in the beautiful Salisbury countryside, with free on-site parking; easy access to London and the south coast

* Onsite canteen.

* Onsite nursery

The successful candidate will be joining Regulatory Affairs and Pharmacovigilance, who provide three significant roles for the organisation: executing on functional delivery tasks, driving strategy internally and influencing regulators and stakeholders across the functional areas of Regulatory Affairs, Market Access, Pharmacovigilance, Medical Information and Environmental including management of Porton Biopharma's licenses and marketing authorisations. As Head of Regulatory Affairs for Porton Biopharma, the post holder will lead, manage and direct all aspects of Regulatory Affairs. The individual will also be required to play a key role in supporting the Regulatory Affairs team members in the evaluation of marketing authorisation applications, variations and other regulatory submissions.

*Key responsibilities*

* Management of Regulatory Affairs Staff

* Establish policies appropriate for the function. Interpret and recommend modifications to company-wide policies and practices. Develop and is responsible for budgets, schedules, and performance standards.

* Ensure that the regulatory requirements of all statutory bodies are met.

* Establish a high level of credibility and manage strong working relationships with external parties including regulatory authorities, customers, advisors and auditors.

* Manage and maintain regulatory licenses and approvals relating to manufacture, testing and distribution of medicinal products by PBL.

* Be PBL's point of contact for regulatory authorities, customers, UK Government Departments on regulatory affairs as appropriate.

* Respond to regulatory authority periodic requests for technical or administrative information about PBL's products.

*Person Specification*

* Have current right to work in the UK;

* Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

* Previous experience that provides the knowledge, skills, and abilities to perform the job.

* Interacts with senior management, and others concerning matters of significance to the company. Conducts business and technical briefings for senior and top management and for external management and / or representatives.

* Demonstrable experience of operational / strategic practice in organisation change to meet business requirements and ensure continuity of service

* An understanding of the key strategic regulatory challenges aims for department, e.g. financial management of costs and risks associated with licenses biologic pharmaceuticals; the commercialisation process for biologics products; challenges associated with manufacturing scale-up / clinical trials.

* Knowledge of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management; superior understanding of ICH and other global regulatory guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC, publishing, etc.

* Management of marketing authorisations and / or clinical trials including liaison and preparation of with regulators.

* A strong reputation for delivery thus being viewed as a trusted advisor to internal clients

* Excellent communication skills in a complex multi-stakeholder context

* Ability to develop and internally market new strategies and policies that will improve Corporate performance

* Ability to develop and implement new strategies and policies that will improve Corporate performance

* Demonstrable ability to turn strategy into operational performance and an ability to deliver through others

.For this unique opportunity to join our team and develop your biopharmaceutical career experience, please submit your CV and a covering letter. You should outline the skills and experience you have, which are relevant to the post for which you are applying. For more guidance on role requirements, please visit our website, portonbiopharma.com/careers, to download the Job Description.

PBL is an equal opportunities employer, celebrating and encouraging diversity of applications.

[Porton Biopharma Ltd is committed to the fair and transparent processing of applicant data. To enable the Company to assess suitability for advertised roles, we will collect the following data: name and contact details, previous work experience and history, qualifications, education, right to work in the UK eligibility, present salary and equal opportunities. The Company reserves the right to collect this data under article 6(1)(B) of the GDPR. ]()

Applicants applying for this role will have their data collected and held securely, and confidentially within Company IT systems which are compliant with GDPR. Data will be shared with the HR department, recruiting managers and recruiting panel.

The Company will hold applicant data on file for 12-months post the vacancy being successfully filled. Candidates are welcome to request that their personal data is removed prior to this date, and should contact [] if they wish to exercise this right. The Company complies with all data subject rights as outlined on the ICO Website. For more information, please refer to our privacy notice: []().

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