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Associate Director - Regulatory Affairs Labelling

Employer
Hobson Prior
Location
England, Berkshire, Maidenhead
Salary
GBP74000 - GBP97000 per annum
Start date
6 May 2022
Closing date
3 Jun 2022

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Discipline
Regulatory Affairs, Labelling
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Hobson Prior are currently looking for an Associate Director - Regulatory Affairs Labelling to join a brilliant Pharmaceutical organisation on a permanent basis located in Maidenhead. Our client is focused on developing treatments that can possibly change the lives of people suffering from serious illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • For this role, you will be responsible for cooperating with suitable shareholders for management of linguistic audits and labelling translations.
  • Accountable for labelling change control effect assessment and tracking actions.
  • You will sanction artwork for packaging mechanisms.
  • Serve as a Subject Matter Expert in charge of offering direction on artwork labelling needs, labelling change control, and E2E tracking actions.
  • Assist with producing and maintaining SOPs, work instructions, job aids, and user guides outlining labelling procedures and best practices to guarantee international compliance.
  • Cooperate with labelling method, regulatory tactic, quality, supply chain, commercial and any other shareholders to guide the development and keep allocated products artwork, mock-ups up to date.
  • When required, you will support the report life cycling in eDMS.
  • The ideal candidate will assist with the enhancement of the international labelling function and aid in planning/forming systems and procedures.
  • Any other assigned duties.

Key Skills:

  • Social capabilities, with the ability to work well in a team setting, with personnel in other divisions at all levels of the organisation, CROs and external consultants. as well as self-sufficiently.
  • Communication skills, involving negotiation abilities.
  • Able to be organised and handle projects with a high attention to detail and the capacity to handle various projects simultaneously.

Requirements:

  • Educated to a degree level.
  • Familiar with regulatory, labelling, packaging, project management and/or quality within a biopharmaceutical organisation.
  • Experience with US, EU and international guidelines, standards and direction reports to labelling pharmaceutical products.
  • Computer literacy with systems such as word processing, spreadsheets, databases, online research which involves proposal-ready configuring.
  • Experience with VEEVA proposals and quality modules, international labelling artwork management system(s), and SPL.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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