Regulatory Labelling Manager

Job description

An excellent opportunity as a Senior Manager, Regulatory Labelling has become available with my global client, on an initial 12 month contract basis.

*Brief Description:*

As the Senior Manager, Regulatory Affairs Labelling Operations, you will be responsible for regulatory support (both technical and operational) in the area of product labelling. You will report to the Associate Director, Labelling Operations and will be responsible for the creation and maintenance of regulatory text; printed labelling materials throughout the product lifecycle, with primary focus on packaging and artwork for products marketed globally.

*Essential Functions*

* Maintain controlled records for historical, current, and ending labelling changes, and communicate labelling changes to stakeholders at the time of implementation
* Represent Labelling function within change control management of printed materials
* Support assigned team(s) by leading activities to ensure timely and compliant implementation of printed labelling materials (for both new commercial products and as a result of labelling variations and regulatory filing activities from a labelling perspective)
* Manage collaborative and solution-focused communication among all stakeholders
* Support the process for linguistic review and translation of label content
* Maintain a current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to product labelling. Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or process changes as needed.
* Develop and provide metrics and reports related to labelling operational processes and systems to leadership and key stakeholders, as required
* Management of product information on corporate labelling webpages, as well as participating in audit and inspections as required.
* Assist in implementing process improvements to increase the efficiency and effectiveness of the label artwork process.
* Responsible for labelling implementation into printed materials, to ensure that labelling documents are produced in a timely manner according to internal SOPs and external regulatory requirements.
* Responsible for proofreading and departmental QC work.
* Lead and manage more junior labelling roles as required.

*Required Knowledge, Skills, and Abilities*

* Experience in the pharmaceutical industry, with direct experience in Global Labelling or in other regulatory affairs function(s).
* Proven experience in regulatory affairs with particular focus on labelling. Experience associated with global product labelling regulations strongly desired.
* Strong judgement and decision-making skills.
* Excellent verbal and written communication skills and collaborative interpersonal skills.
* Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
* Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism.
* Ability to travel occasionally - approximately 10-20% regional and/or international travel.
* Responsibilities may require working outside of "normal" hours, in order to meet business demands.
*
Required/Preferred Education and Licenses*

* Bachelor's degree required (Scientific discipline preferred) (or equivalent industry related experience)

For further details, please contact Tim Barratt at Achieva on or email