Artwork Manager – Regulatory Affairs

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India

Artwork Manager – Regulatory Affairs

LOCATION: Vadodara
POSTED 07/10/2024

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The Role

• Assist the Head of Regulatory in the management of the product portfolio of regulatory artworks.
• Take a leading role in management of artworks, request for preparation of artworks to studio, proof-reading, controlling versions and coordinate with manufacturing and packaging sites till printing of artworks. 
• Awareness of relevant pharmaceutical regulation and new guidelines/policies (EU/blue box labelling guidelines) relevant to product information/safety variation.
• Assist with the organisation and execution of designated regulatory projects, to agreed timelines, in conjunction with colleagues and third-party organisations. 
• Maintain artwork compliance through timely submissions of safety and comparison with in-line with brand leader variations.

Job Responsibilities

• Manage creation of labelling text and artworks, liaise with studio for update/amendments, proof-read for correctness for submission to regulatory agencies.
• Liaise with relevant internal and external departments/consultants for preparation/submission and approval of artworks as per local requirement.
• Ensure that artwork complies with local requirements like for EU – Blue box requirements.
• Liaise with CMO for finalising print-proof of artworks for printing.
• Instigate any relevant information received from PRAC/safety update.
• Assist other regulatory colleagues for timely submission of Marketing Authorisation, national phase applications and Variation applications, artwork submissions, responses to regulatory questions, and renewal applications.
• Contribute to setting up departmental procedures, policies and systems, and assist with training and implementation.
• Liaise with relevant internal and external departments/consultants for preparation and submission of artworks as per local requirement.
• Management of Pharmacovigilance database, safety variations for PV activities and monthly reconciliation.
• Manage artwork tracker and regulatory logs as per SOP.
• Update approved product information on local medicines portal (like eMC for UK), like update of approved product information like leaflet, SmPC, risk minimisation measures, educational material etc
• Adhere to company SOP/policy for creation, maintenance, printing to future updates of artworks.
• Contribute to setting up Departmental procedures, policies and systems, and assist with training and implementation.
• Other duties as assigned.

Your Experience & Skills

7 to 8 years’ experience for the following

• Artwork creation and maintenance
• Management and control of procedures
• Beneficial if candidate has knowledge of use of Adobe Illustrator for artwork corrections

Hours and working arrangements:

• This is a permanent role, and whilst full time (5 days per week) The role is predominately on-site.

Next Steps

• If this sounds like the right role for you, then we welcome your application.

We endeavour to reply and feedback to all applications; however, when a popular role becomes available, it’s not always possible, so if you have not heard from us within 30-days please assume that we couldn’t take your application further on this occasion.

We are committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination.   The aim is for our employees to be truly representative of all sections of society, and for each employee to feel respected and able to give their best.

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