Regulatory Manager, Labelling

Beschreibung:

In your new role as the Established Products Global Labelling Manager you will:
* manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment
* participate in development of the Company Core Datasheet (Global Product Information) for new medicines or product line extensions
* support global/country/regional labelling in compliance with (COMPANY NAME) Labelling processes and external requirements
* act as subject matter expert in (COMPANY NAME) Labelling process
* identify risks to quality and/or timely completion of project, resolving any issues and escalating items to be resolved at a higher management level
* participate in projects and activities, such as identifying areas for improvements/efficiencies and leading implementation of changes to labelling processes
* build and maintain quality relations with your internal and external stakeholders
* work closely with your peers and manager to drive standardization across the business

Basic qualifications:
* proven experience in regulatory area, labelling experience is preferred
* higher education in life sciences/ pharmacy
* sound understanding of pharmaceutical industry, drug development environment and regulatory processes
* well-developed understanding of labelling (e.g. significant experience in managing local labelling documents/submissions and/or management of global labelling documents)
* strong interpersonal and communication skills and ability to present information in a clear and concise manner
* Attention to detail, excellent organization and time management skills
* ability to perform multiple tasks, set the right priorities to deliver objectives on time
* adaptable to changing circumstances through priorities reassessment and a disciplined, logical work style
* fluent English and Polish (both verbal and written)

Preferred qualifications:
* well-developed leadership skills
* negotiation and problem solving skills
* project management and team management experience would be an asset

At (COMPANY NAME) we offer a wide range of additional benefits: 
* Career at one of the leading global healthcare companies
* Hybrid work ( 2/3 days per week from the office)
* Temporary Contract of employment (approx. 18 months)
* 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. 
* Sports cards (Multisport)
* Possibilities of development within the role and company's structure
* Personalized learning approach (internal trainings, mentoring, access to online training' platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
* Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
* Supportive community and integration events
* Modern office with creative rooms, fresh fruits every day

#LI-(COMPANY NAME)
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Why (COMPANY NAME)?
Uniting science, technology and talent to get ahead of disease together.

(COMPANY NAME) 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 (COMPANY NAME) a place where people can thrive. We want (COMPANY NAME) 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.

If you require an accommodation or other assistance to apply for a job at (COMPANY NAME), please contact the (COMPANY NAME) Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

(COMPANY NAME) 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
(COMPANY NAME) 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 (COMPANY NAME)'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to (COMPANY NAME). The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and (COMPANY NAME). 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 (COMPANY NAME). (COMPANY NAME) shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site