HUB Labelling Manager - Russian speaker
A well-known international pharmaceutical company with sites around the globe is looking to hire a HUB Labelling Manager - Russian speaker. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Preparing local product labelling documents and their associated local language labelling documents for the Eurasian Economic Union (EAEU), and other markets.
- Updating the labelling documents on a timely basis according to internal SOPs and external regulatory requirements.
- Supporting other HLMs and will collaborate with Regulatory and Medical leaders based in various countries including UK, USA, Russia and other EAEU countries.
- Acting as a Subject Matter Expert (SME) on local, regional and multi country regulatory labelling requirements and participate in the sharing of intelligence.
- Delivery and management of labelling text through the appropriate processes and systems, and through interaction with colleagues in other roles.
- Utilisation of regulatory expertise and analytical skills to review and develop appropriate content for local labelling documents based on existing approved content, seeking strategic and medical input from others as required, and recording any decisions made.
- Communication, planning, prioritisation and delivery of labelling documents according to company targets and submission requirements.
- Answering queries from client colleagues in response to inspection activities and regulatory agency questions.
- Liaison with stakeholders using the most effective means of communication; presentation of information in an optimal format and level of information for that audience.
- Ongoing development of labelling and subject matter expertise for assigned markets; the focus is expected to be on EAEU markets.
- Working within a framework of internal standard operating procedures (SOPs), working practices, and external regulatory requirements, so that the high-quality delivery of outputs and compliance is maintained.
- Appropriately tracking labelling projects via defined procedures and systems.
- Ensuring that decisions taken for labelling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely manner.
- Supporting the use of relevant tools and technologies within the course of the label development and translation process.
- Knowledge of regional regulatory regulations and guidelines pertaining to labelling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.
- Ability to understand, analyse and propose information to be included in local labelling documents and the ability to logically review any impact on other sections of the same documentation.
- Ability to delegate work to others, including working with internal and external vendors.
Skills and Requirements:
- 1 year of pharmaceutical experience.
- Experience of working within corporate systems and procedures.
- Experience of delegating work to others or working with vendors.
- Excellent project management skills, and ability to plan, prioritise and deliver within specific deadlines.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Written and verbal communications should be clear and effective; fluency in English and Russian.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Numhom Sudsok at 0203 871 8093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.