Labeling Manager Pharmaceutical Regulatory Affairs

Presentation

For upcoming consultant assignments we are now looking for a Labelling Manager with Regulatory Affairs knowledge for consultant assignments that will start during the spring and go on for varied length.

Interviews and selections are held continously so please apply today!

Arbetsuppgifter

As a Labeling Manager you will be responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products. You will coordinate packaging component, labeling content development and support the labeling content development of USPIs and other regional labeling.

Your main tasks will be:

- Point of contact for Regulatory Affairs towards the process for the creation, approval, and implementation of commercial printed labeling
- Coordinate leads cross-functional teams in the development and lifetime maintenance of regional packaging component labeling
- Provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design
- Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission
- Understand industry labeling trends related to packaging and labeling implementation
- Ensure proper version control and document integrity of packaging component labeling and printed labeling artworks
- Originate precedent searches, create and maintain labeling comparisons, and analysis of competitive labeling
- Interact with Marketing Company colleagues
- Oversee EU translations process as appropriate
- Interact with appropriate functional groups to obtain labeling annotations and supporting documentation
- Coordinate Content of Labeling/Drug Listing SPL generation and review
- Draft summaries of relevant labeling changes
- Maintain labeling history documents and assist in responding to labeling-related queries
- Maintain repository of current labeling documents, including appropriate website repositories
- Process and prepare all US Final Printed Labeling and required EU specimens for submission
- Manage annual review of product labeling galley proofs
- Serve as document management system administrator role
- Assist Global Labeling team in resolution of labeling issues
- Help ensure regional submission timelines
- Help ensure corporate quality standards for labeling
- Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function
- Represent functional expertise at relevant department meetings
- Assist in other regulatory activities as required

Utbildning/erfarenhet

We think that you have a University Degree in Science or related discipline and Pharmaceutical experience, preferably regulatory experience, preferably working with labeling. You have knowledge of labeling regulations and guidances, keen attention to detail and accuracy, excellent verbal and written communication skills, Multi-cultural awareness and sensitivity and demonstrated experience effectively communicating and negotiating in diverse cultures as well as competencies in building relationships, negotiation and critical information seeking. Please apply in English.

Förmåner

We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning

Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

Sluttext

Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.

Language

en-GB