- Manage Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.
- Prepare registration files, clinical trials applications, variations, renewals files, and responses to Regulatory Agency inquiries.
- Collaborate with global colleagues and Regulatory Affairs to deliver high-quality dossiers and materials aligned with business priorities.
- Ensure technical congruency and regulatory compliance in partnership with authors.
- Update systems and procedures to maintain proper records and support controls.
- Provide evaluations for potential changes and ensure regulatory compliance.
- Communicate regulatory requirements and guidelines to facilitate timely submissions.
- Stay updated on guidelines, regulatory requirements, and technical trends.
- Bachelor's degree in Pharmaceutical or Life Sciences or equivalent regulatory experience.
- Minimum of 2 years of experience in regulatory affairs, including chemistry, manufacturing, and controls, and over-the-counter experience.
- Knowledge of regulatory submissions to markets.
- Ability to ensure compliance standards and meet key performance indicators.
- Regulatory expertise in the knowledge of the regulatory life cycle.
- Ability to interact effectively at multiple levels.
- Technical knowledge.
- A fast-paced organizational and business environment.
- An opportunity to learn from a variety of healthcare products and to be exposed to European market and regulatory environments. Learning and development opportunities.
- Market-leading policies such as our 26-weeks equal parental leave.
- Highly competitive compensation and benefits package.
- Employee Assistance Program.
-
Connectivity Specialist Benelux
1 week geleden
BAXTER Vilvoorde, België**This is where you save and sustain lives** · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves ...
-
Tender Specialist Benelux
1 week geleden
Mölnlycke Berchem, België**Do you have what it takes to make a difference?** · If the answer is yes, join our team In our daily work, we create unique medical solutions to improve the quality of life. We enjoy what we do because it makes a difference in people's lives - for real. · The Tender & Sales Sup ...
-
Field Marketing Specialist- Benelux
1 week geleden
Acolad Brussels, BelgiëBrussels, Brussels, Belgium · - Global Marketing & Pre-Sales · **Description**: · **Acolad is an international leader in language and content solutions, services and technologies. Represented by the brands Acolad, TextMaster and Ubiqus, the group is present in 25 countries and ha ...
-
Order Administration Specialist Benelux
4 dagen geleden
Quadient Zaventem, België**_Order administration Specialist Benelux_** · **Als Order administration Specialist** · - Kijk je de bestellingen van onze machines na en zet je deze door · - Behandelen van bestellingen van supplies voor onze machines · - Start je nieuwe contracten op en zet je ze stop wanneer ...
-
Field Marketing Specialist- Benelux
1 week geleden
Acolad Brussels, België**Acolad is an international leader in language and content solutions, services and technologies. Represented by the brands Acolad, TextMaster and Ubiqus, the group is present in 25 countries and has a network of over 2,500 internal experts worldwide and +20,000 external linguist ...
-
Quality Specialist Benelux
1 week geleden
Abbott Laboratories Wavre, BelgiëFor our Diabetes Care division, we are recruiting a Quality Specialist Benelux to be based in our Wavre office. · Role and Responsibilities: · - Ensure that the Quality Management System conforms to customer, internal, ISO 13485 and regulatory/ legal requirements · - Report to th ...
-
Project Specialist Benelux
1 dag geleden
Gruppo Arcese Boom, BelgiëIf you're passionate about driving growth and thrive in a fast-paced environment, this is your chance to make an impact. · As a key player, you'll be instrumental in supporting our main projects, from revolutionizing transport solutions to optimizing warehousing strategies. Be th ...
-
Software Solutions Specialist Benelux
11 uur geleden
Glory Global Solutions (Belgium) Asse, België**COMPANY OVERVIEW** · As a global leader in cash technology solutions, we provide the financial, retail, cash centre and gaming industries with confidence that their cash is protected and always working to help build a stronger business. · Our cash automation technologies and pr ...
-
Tax Specialist Benelux
5 dagen geleden
3M Machelen, België VoltijdJob Description: · Collaborate with Innovative 3Mers Around the World · Choosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, and its leaders, will ...
-
Benelux Field Marketing Specialist
1 week geleden
Unit4 Antwerpen, BelgiëCompany Description · Meet Unit4. We're a fast-paced growth cloud company, changing the game in ERP for mid-market people-centric organizations. We're on a mission to turn 40 years of conventional legacy ERP software on its head and re-write the industry. · We are in Business for ...
-
Benelux Field Marketing Specialist
1 week geleden
Unit4 Antwerpen, België**Company Description**: · Meet Unit4. We're a fast-paced growth cloud company, changing the game in ERP for mid-market people-centric organizations. We're on a mission to turn 40 years of conventional legacy ERP software on its head and re-write the industry. · We are in Busines ...
-
Media Specialist Benelux
4 dagen geleden
MediaMarktSaturn Retail Group Grimbergen, BelgiëWat ga je doen? · We are seeking an energetic and proactive Media Specialist to join our marketing team and support the Media Manager in managing media campaigns across Belgium, Netherlands, and Luxembourg (Benelux). The Media Specialist will play a crucial role in ensuring the ...
-
Customer Support Center Specialist Benelux
1 week geleden
Abbott Laboratories Wavre, België**About the organization** · Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks and clinics. Our products offer automation, convenience, cost-effectiveness and flexibilit ...
-
Display & Social Specialist Benelux
3 dagen geleden
Agilitas Group NV Asse, BelgiëVoor onze klant in Asse zijn we op zoek naar Display & Social Specialist. Wil je graag je eerste stappen zetten binnen de marketingsector? of nog beter: heb je reeds ervaring met communicatie, marketing en/of merchandising? Dan is deze functie helemaal op jouw lijf geschreven · * ...
-
Field Marketing Specialist- Benelux
5 dagen geleden
Amplexor Brussels, BelgiëDescription: · Acolad is an international leader in language and content solutions, services and technologies. Represented by the brands Acolad, TextMaster and Ubiqus, the group is present in 25 countries and has a network of over 2,500 internal experts worldwide and +20,000 ext ...
-
Project Specialist BeNeLux
4 dagen geleden
Arcese Boom, BelgiëProject Specialist BeNeLux · Ritorna alle posizione aperte Location · Boom · Contract type · Full Time · Departments · Sales & Marketing · If you're passionate about driving growth and thrive in a fast-paced environment, this is your chance to make an impact. · As a key playe ...
-
Specialist, CQA Benelux
1 week geleden
Baxter Braine-l'Alleud, België VoltijdThis is where you save and sustain lives · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves out ...
-
Payroll Specialist BeNeLux
2 weken geleden
Walters People Mechelen, België permanentEen internationaal bedrijf gespecialiseerd in industriële gereedschappen en gelegen in Mechelen is op zoek naar een Payroll Specialist BeNeLux (remote) voor de entiteiten in België, Nederland en Luxemburg. Je superviseert en monitort alle payroll activiteiten voor de Benelux regi ...
-
Customer Support Center Specialist Benelux
1 week geleden
Abbott Laboratories Wavre, België VoltijdAbout the organization · Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks and clinics. Our products offer automation, convenience, cost-effectiveness and flexibility. A ...
-
Regional Controller Emerging Markets and Benelux Ep
11 uur geleden
Abbott Laboratories Zaventem, BelgiëWe are currently recruiting for a Regional Controller Emerging Markets and Benelux Electrophysiology, to be based in Zaventem, Belgium. · The Regional Controller has the full responsibility over the P&L of Region Emerging Markets & Benelux (MEA, Russia & CIS, EE, Israel & Turkey, ...
Regulatory Affairs Specialist Benelux - Zaventem, België - Haleon
Beschrijving
Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business.
This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.
As Regulatory Affairs Management Professional you will be responsible for the execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.
Key Responsibilities:
Basic Qualifications:
Preferred Qualifications:
What we offer:
Care to join us. Find out what life at Haleon is really like
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity 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.
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, Haleon may be required to capture and report expenses Haleon 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 Haleon's compliance to all federal and state US Transparency requirements.