Reference Number: JO-2308-520943
Regulatory Labelling Consultant
Rate: Negotiable
Job Type: Permanent
Location: Hatfield

Regulatory Labelling Consultant

6-12 Month initial contract

Offering up to £75.00 Per Hour PAYE DOE

Flexible working, 2 days per month required onsite, Hertfordshire based

ASAP Start

An exciting opportunity has arisen with a global Pharmaceutical Company supporting their Generic portfolio, working as a Regulatory Labelling Consultant. Within this position you will be responsible for the creation, verification, maintenance and justification of Safety and Regulatory compliant Product Information (PI) texts (Labelling). Reporting to the Senior Manager of Core Labelling Operations you will assist with support labelling strategy and develop and establish territorial Label documents. A backgrounds working in a generic environments would be highly advantageous.

Job Responsibilities includes;

• Provide Labeling strategy (in close collaboration with SME for pre-/clinical development/program, definition of indication, posology etc) where applicable.

• Develop and establish territorial Label documents for product, e.g. Monograph, SmPC, PI or RSI, as appropriate

• Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, CCDS or Brand Leader (or other Legal Basis Reference Product). As required, this includes locating and confirming the validity of such information.

• Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.

• Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.

• Working with Global Product Safety and Risk Management – Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue for endorsement of recommendations

Candidate Requirements;

• Eligibility to live and work in the United Kingdom

• Life Sciences Degree of the equivalent

• 4 years global Labelling and Labelling development experience, preferably in Generics.

• Ability to provide innovative approaches to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.

• Understand EU/ US regulatory requirements.

If this opportunity is of interest to you please forward your CV to Sophie on sophie.malyon@cpl.com.

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