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.