Position: Regulatory Project Manager – replacement contract (expected employment period of over 1 year)
Work Location – Warsaw, Poland
Work Mode – Hybrid (3 days in the office, 2 days from home)
About the position
As a Regulatory Project Manager in our Regulatory Affairs team, you will lead registration processes for our portfolio of medicinal products and support business units in building product strategies. Ready to get started?
Join a team that provides patients with access to life-changing medications. In Regulatory Affairs, you will manage complex registration processes, collaborate directly with regulatory authorities, and support the market introduction of innovative therapies.
About Sanofi
We are a bio-pharmaceutical company driven by research and artificial intelligence, committed to improving people's lives and achieving significant growth. Our deep understanding of the immune system and our innovative pipeline allow us to create medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main responsibilities
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Leading registration, re-registration, and post-registration change processes by submitting required documentation, updating it, compiling it, and creating necessary documents to ensure the registration of medicinal products in Poland
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Maintaining close contact with regulatory authorities involved in the drug marketing authorization process to obtain the appropriate registration decisions
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Developing the substantive content of the Summary of Product Characteristics, patient information leaflets, and packaging labeling, including translations for products under the centralized procedure
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Preparing drug information for promotional materials
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Participating in regulatory projects
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Close cooperation with other departments in the company to achieve business objectives
About you
Experience:
- Professional experience in a pharmaceutical company or government institutions, including experience working in the Regulatory Affairs area
Skills:
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Very good knowledge of pharmaceutical law
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Very good knowledge of registration procedures and legal regulations regarding the marketing authorization of drugs in Poland and the European Union
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Good self-organization – ability to set priorities
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Attention to detail, meticulousness
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Analytical thinking and problem-solving skills
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Customer orientation and very good communication and collaboration skills
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Fluent knowledge of MS Office (Word, Excel, and PowerPoint)
Education:
- Higher education in medicine, pharmacy, or a related field
Languages:
- Advanced knowledge of English (business and medical) in speech and writing
Why join us?
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Join a leading pharmaceutical company and contribute to improving people's health worldwide
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Be part of a company at the forefront of medical research and breakthrough therapies
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Grow in an environment that values diversity of thought and background
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Work in a Manager position within the Registration Department with the opportunity to expand your knowledge of pharmaceutical law
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Participate in the registration process of innovative products and interesting projects related to the introduction of new products
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Gain autonomy in your work within assigned tasks and the opportunity for individual professional development within the Sanofi Group
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Benefit from an attractive package of benefits including, among others, medical care for employees and their family members, an employee pension insurance program, life insurance, and a range of social fund benefits including a Multisport card
Information for candidates for employment at Sanofi
By applying for a position within the Sanofi Group in Poland, you provide us with your personal data. In connection with the above, we would like to inform you how the companies:
· Sanofi sp. z o.o. with its registered office in Warsaw at ul. Marcina Kasprzaka 6, 01-211 Warsaw, or
· Opella Healthcare Poland sp. z o.o. with its registered office in Warsaw at ul. Marcina Kasprzaka 6, 01-211 Warsaw,
will process your personal data if you decide to share it with us for the purpose of including your application in our recruitment process.
Personal Data Controller
From the moment you provide us with your personal data (hereinafter referred to as "Personal Data"), the Sanofi company to which you are applying becomes their Controller, which means that it will decide for what purpose and in what way your Personal Data is processed in its database.
The Controller will always be the company to which you are applying for a position (hereinafter also referred to as the "Controller" or "we", "us", "our" etc.). Regardless of which of the above-mentioned Sanofi companies is the Controller, the principles of processing Personal Data in the recruitment process are identical.
Source of Personal Data
We may obtain your Personal Data from the following sources:
a. directly from you (e.g., when you send us your application yourself, respond to our job offer, fill out our recruitment form, come to a recruitment meeting);
b. from databases maintained by agencies (recruitment companies) where you have registered as a job seeker, provided that you have given consent for such an agency to share your Personal Data with us for recruitment purposes,
c. from your previous employers, if you voluntarily agree for us to ask them to provide us with feedback on how they evaluated you as an employee (so-called references),
d. from internet portals where you publicly post information about your professional experience, education, interests, career path, etc. (e.g., LinkedIn).
Purpose of Personal Data processing
We will process your Personal Data for the needs of conducting the recruitment for which you are applying for a specific job position. If you agree, we will also process your data in future recruitment processes if you were not selected for employment for the position you originally applied for. With your consent, we will share your Personal Data with other companies in the Sanofi Group so that they can also present you with their job offers and invite you to participate in recruitment processes.
Legal basis for data processing
We process your Personal Data in accordance with EU Regulation 2016/679 of April 27, 2016 (General Data Protection Regulation), hereinafter referred to as "GDPR", acting on the basis of:
a. labor law provisions, in particular the Labor Code, which indicate what data an employer should obtain from a job candidate (legal basis: Art. 6(1)(c) and Art. 9(2)(b) of the GDPR),
b. your consent to data processing (legal basis: Art. 6(1)(a) and Art. 9(2)(a) of the GDPR), in cases where:
· you voluntarily provide us with more Personal Data than required by labor law,
· you grant a recruitment agency (company) where you have registered in the database permission to share your Personal Data with us for the purpose of including your application in our recruitment process,
· you grant us consent to process your Personal Data in future recruitment processes,
· you agree for us to share your Personal Data with other Sanofi Group companies for their own recruitment purposes.
Providing the above consents is voluntary and they can be withdrawn at any time. Please note, however, that exercising the right to withdraw previously granted consent will not affect the legality of our actions that were carried out based on your consent before it was withdrawn.
c. the realization of our legitimate interests consisting in enabling us to defend ourselves in the future against potential claims in the field of equal treatment and discrimination in employment (legal basis: Art. 6(1)(f) and Art. 9(2)(f) of the GDPR).
Data recipients
Access to Personal Data may be granted to the following data recipients:
· authorized employees of the Controller and service providers (these may be Sanofi Group companies or external suppliers), if access to the data is necessary for such a service provider to perform services for the Controller. In particular, these include entities such as recruitment agencies (companies) that look for the best job candidates for us or support us in such searches. If we have received your personal data from a recruitment agency, in such a case we may share information with that agency regarding your employment to the extent necessary to settle the agency's remuneration for a successful recruitment result if you are hired. Furthermore, entities providing us with IT tools and systems used for data processing in recruitment processes, including providers of internet portals for job seekers, may also have access to your data. However, access to Personal Data is always granted only to entities for which there is a justification for such access due to the tasks performed and services provided. We ensure that our employees undergo appropriate training in the field of personal data protection by familiarizing them with internal data protection policies and procedures or dedicated training programs. All persons authorized to process Personal Data are obliged to maintain data confidentiality and secure it against disclosure to unauthorized persons.
· entities from the Sanofi Group, to which Personal Data is shared for use in their own recruitment processes, if you have given us consent for such data sharing.
Data transfer to third countries (countries outside the EEA)
Personal Data may reach recipients in any of the countries where the Sanofi Group conducts its business. Some data recipients may be located in countries outside the European Economic Area (EEA) that do not provide the same level of personal data protection as countries belonging to the EEA. In such a case, the Controller applies appropriate mechanisms aimed at protecting Personal Data, including in particular the Binding Corporate Rules of the Sanofi Group or a data transfer agreement based on standard contractual clauses adopted by the European Commission. To obtain further information on the countries to which data is transferred or the data transfer mechanisms used, you can contact the Controller using the contact details provided below.
Data retention period
Personal Data will be stored for the duration of the recruitment, and in the case of non-selected candidates, also for 3 months after its completion, solely for the purpose of using it if necessary in recruitment for the same position, e.g., in the event that the originally selected candidate resigned from the job offer. After the final completion of a given recruitment, we may, however, retain your Personal Data for the purpose of defense against potential claims in the field of equal treatment and discrimination in employment, but no longer than until the expiry of the limitation period for these claims, which is 3 years (in the case of initiating proceedings before a court, this period is extended until the end of such proceedings). If, however, you agree to the processing of your Personal Data in future recruitment processes, we will process them for these purposes no longer than until you withdraw your consent. In the event that you are hired as a result of the recruitment, we will process your Personal Data as part of the employment processes. Detailed information on the processing of employees' personal data will be presented to you at the stage of concluding an employment contract.
Data collection principles
Providing Personal Data is mandatory to the extent indicated in Art. 22¹ § 1 and 4 of the Labor Code. You provide any additional information voluntarily by giving consent to their processing. Failure to provide the required data will result in the rejection of your application in the recruitment process.
Rights related to the processing of Personal Data
As a data subject, you can exercise the following rights against the Controller:
a. the right to request access to your Personal Data and obtain information about its processing, and in the event that it is incorrect, the right to request its rectification (in accordance with Art. 15 and 16 of the GDPR),
b. the right to request the restriction of the processing of your data in situations and on the terms indicated in Art. 18 of the GDPR (Every data subject may request the restriction of the processing of their personal data for the period of verifying its accuracy or until their objection to data processing is considered. This right also applies in a situation where, in the opinion of the data subject, the processing of their data is unlawful, but they do not want this data to be deleted immediately, or in the case where the data is needed for longer than the assumed processing period, due to issues of establishing or defending claims),
c. the right to withdraw previously granted consent to the processing of Personal Data, which, however, will not affect the legality of the processing of your data that took place based on this premise and occurred before you exercised your right to withdraw consent,
d. the right to request the deletion of data in accordance with Art. 17 of the GDPR ("right to be forgotten"),
e. the right to transfer Personal Data in accordance with Art. 20 of the GDPR, i.e., to receive your personal data from the Controller in a structured, commonly used, machine-readable format (by computer), as well as to request its transfer to another data controller; This right applies only to data that you provided to us yourself, processed based on your consent, and in electronic form,
f. the right to object to further data processing in accordance with Art. 21 of the GDPR.
Furthermore, you have the right to lodge a complaint regarding the processing of your Personal Data by the Controller to the President of the Personal Data Protection Office (address: ul. Stawki 2, 00-193 Warsaw).
Contact details of the Controller and its data protection officer
To contact the Controller in order to exercise the above-mentioned rights regarding the processing of personal data, please visit the website: https://www.sanofi.com/en/data-protection-contact (opens in new window)
To contact our Data Protection Officer, please send an email to: [email protected](opens in new window)
The Controller may keep in its resources the Personal Data of the person submitting an application or request to the extent necessary to document that its consideration took place in accordance with the law. This data will be processed no longer than until the expiry of the limitation period for claims, which constitutes the legitimate interest of the Controller referred to in Art. 6(1)(f) of the GDPR.
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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :zł139 200,00 - zł185 600
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.