Senior Regulatory Specialist, Country Labelling

7 miesięcy temu

Warsaw, Polska 9605 GSK Services Sp z o.o. Pełny etat

The Senior Regulatory Specialist, Country Labelling is responsible for effective coordination, communication and maintenance of regional/country labelling documents (for multiple markets/regions) and data in regulatory systems in accordance with defined standards and processes. You will provide support to GRA Labelling colleagues, Regulatory Matrix Teams and Local Operating ompanies to ensure timely update, management and communication of quality regional and local labelling/Product Information (PI) and supporting documentation required for local submissions.

In your new role as the Senior Regulatory Specialist, Country Labelling you will be responsible for:

Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.

Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.

Provide support to global and local GRA team members through preparation of other labelling documents as required.

Complete quality and consistency checks of labelling document content.

Efficiently coordinate and manage labelling documentation and data in regulatory systems.

Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.

Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.

Support other regulatory functions and participate in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.

For some roles, may be required to perform translation of labelling text into identified languages.

Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements:

provides coaching, mentoring and knowledge sharing within GSK Labelling skill group

completes quality checks for colleagues’ outputs

effectively manages interactions with Senior Stakeholders

takes accountability for the management of labelling deliverables for country/region, including delivery of high-quality outputs to timelines

Requirements:

Relevant experience (in pharmaceutical industry, life sciences research or regulatory)

Masters degree Area of Specialisation: Science or Life Sciences ( must have)

Successfully performed within a regulated or quality-critical environment (such as pharmaceutical industry research, pharmacy, safety or regulatory)

Understanding of labelling (e.g. through direct or indirect exposure to the management of labelling documents/submissions/data)

Experience in updating and managing Regional/Country Labeling documents.

Knowledge of labelling regulations/requirements in 1 or more regions ( EU preffered)

Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple tasks

Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner

Ability to think flexibly in order to meet constantly shifting priorities and timelines

Understanding of the pharmaceutical industry, drug development environment, and regulatory processes

Ability to negotiate solutions to moderate labeling issues and proactively identify improvements for labelling processes.

What we offer:

Career at one of the leading global healthcare companies

Hybrid type of work - 2/3 days per week from the office

Contract of employment

Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

Life insurance and pension plan

Private medical package with additional preventive healthcare services for employees and their eligible counterparts

Sports card (Multisport)

Possibilities of development within the role and company’s structure

Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

Extensive support of work life balance (flexible working solutions, health & well-being activities)

Supportive community and integration events

Modern office with creative rooms, fresh fruits everyday

Free car and bike parking, locker rooms and showers

#LI-GSK

#LI-HYBRID

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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