Regulatory Affairs Specialist

il y a 3 semaines

Brainel'Alleud, Belgique BAXTER Temps plein

**Vantive: A New Company Built On Our Legacy**

Baxter is on a journey to spin off our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

**Your Role at Baxter**

**This is where your motivation addresses challenges**

**Your Team at Baxter**

The Specialist (f/m/d) RA belongs to the Benelux CQA and RA department, reports to the CQA/RA Manager Benelux and is responsible to ensure that the product registration lifecycle and related processes are ensured in Belgium, Luxembourg, and the Netherlands

The Regulatory function values both working together as a team and independently. We draw energy from working in collaboration with internal and external stakeholders. As the company evolves, so does the way our team approaches work as it strives to create new development opportunities and new ways of working.

**What you will be doing**:
RA Role

For Renal and Acute Therapy products:

- Respond to questions from regulatory authorities in agreement with the Global Regulatory Lead.
- Ensure high quality labeling translation and artwork management
- Review promotional materials for compliance with local regulations
- Maintain good relationships with internal (Global Regulatory Leads, Pharmacovigilance, Business partners, Market Planners,) and external regulatory contacts (local regulatory authorities)
- Monitor applicable EU and local regulations, perform impact analysis where needed and keep internal partners appropriately informed.
- Provide regulatory guidance to business, tenders and project teams

QA Support
- Support Corporate Quality Systems implementation including local requirements to CQA and distribution
- Coordinate Field Actions implementation
- Handle non conformities, CAPA and change controls
- Provide support in case of inspections

**What you will bring**:

- Bachelor’s degree or country equivalent in a relevant scientific field
- Preferable prior work experience in regulatory or equivalent experience within a pharmaceutical/medical device company, CRO or similar organization
- Native fluency in Dutch or French, with proficiency in English and in the second national language (Written and spoken)
- Office basic knowledge required
- Good interpersonal and communication skills: ability to collaborate closely with different functions involved and with multicultural teams
- Organizational and project management skills, self-motivation and commitments
- Certified RIP from Belgian FAMHP is a plus
- IT functional knowledge in Veeva Vault RIM & PromoMat, TrackWise is an asset
- Proficiency in German is appreciated

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

129019

  • Regulatory Affairs

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique Pauwels Consulting Temps plein

    -braine l'alleudbediende, freelancer40 uur per week Naima MaitTalent Acquisition Specialist Life Sciences- Regulatory Affairs Packaging and Labeling Strategist: Pharma & Sciences Regulatory Affairs Are you passionate about driving innovation in pharmaceutical packaging and artwork strategy? Do you thrive in a dynamic environment where you can make a...

  • Principal Specialist Regulatory Affairs

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique BAXTER Temps plein

    This is where you save and sustain livesAt 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 outcomes for millions of patients.Baxter's products and therapies are found in almost...

  • Principal Specialist Regulatory Affairs

    Il y a 2 mois

    Braine-l'Alleud, Belgique BAXTER Temps plein

    **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 outcomes for millions of patients. Baxter's products and therapies are found in...

  • Regulatory Affairs

    il y a 3 semaines

    Braine-l'Alleud, Belgique Pauwels Consulting Temps plein

    -braine l'alleud bediende, freelancer 40 uur per week - Naima MaitTalent Acquisition Specialist Life Sciences 0032499680850 - **Regulatory Affairs - Packaging and Labeling Strategist**: Pharma & Sciences - Regulatory Affairs - Are you passionate about driving innovation in pharmaceutical packaging and artwork strategy? Do you thrive in a dynamic environment...

  • Regulatory Affairs Manager

    il y a 4 semaines

    Braine-l'Alleud, Belgique PolyPeptide Belgium Temps plein

    Have you been working within the pharmaceutical industry for some time and are you now ready for the next step in your career?_ - Are you interested in Regulatory Affairs?_ - Then, here is an opportunity for you!_ - To strengthen its RA team, the PolyPeptide site in Braine L'Alleud is looking for a_ **_Regulatory affairs manager_** We are searching for...

  • Regulatory Affairs Manager

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique PolyPeptide Belgium Temps plein

    Have you been working within the pharmaceutical industry for some time and are you now ready for the next step in your career?_ Are you interested in Regulatory Affairs?_ Then, here is an opportunity for you_ To strengthen its RA team, the PolyPeptide site in Braine L'Alleud is looking for a__Regulatory affairs manager_We are searching for someone with a...

  • Regulatory Affairs Specialist

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique Baxter Temps plein

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Regulatory Affairs Specialist

    Il y a 2 mois

    Braine-l'Alleud, Belgique Baxter Temps plein

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Regulatory Affairs Specialist

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique BAXTER Temps plein

    Vantive: A New Company Built On Our LegacyBaxter is on a journey to spin off our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care...

  • Regulatory Affairs Advisor

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique Aisin Temps plein

    FunctieomschrijvingAre you a graduate in law? Do you have excellent communication skills in English? Do you have interest in technical field? This job is for youYour missionOur Technical Administration & Legal team, composed of 5 employees, located on the Braine-l'Alleud site, is currently looking for a Regulatory Affairs Advisor to strengthen this team. As...

  • Regulatory Affairs Advisor

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique Aisin Europe Temps plein

    CompanyAISIN EUROPE is part of the Japanese AISIN Corporation, a leading supplier of automotive technology products employing more than 100,000 people worldwide.Our ValuesGrowth & happiness for our employees and colleaguesInspiration & trust for our customersA sustainable environment for the futureAisin Group WayBe proactive, make changes (take on...

  • Regulatory Affairs Advisor

    il y a 3 semaines

    Braine-l'Alleud, Belgique Aisin Temps plein

    Functieomschrijving Are you a graduate in law? Do you have excellent communication skills in English? Do you have interest in technical field? This job is for you! Your mission Our Technical Administration & Legal team, composed of 5 employees, located on the Braine-l'Alleud site, is currently looking for a Regulatory Affairs Advisor to strengthen this...

  • IT Solution Expert Regulatory

    il y a 4 semaines

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Information Technology** team, based in Braine-l’Alleud, Belgium, or Raleigh, North Carolina, US, or UK, we are looking for a talented individual to fill the position of **IT Solution Expert Regulatory & Quality** **About The Role** This role has global responsibility for all IT systems that enable the...

  • Regulatory Affairs Advisor

    Il y a 2 mois

    Braine-l'Alleud, Belgique Aisin Europe Temps plein

    Company AISIN EUROPE is part of the Japanese AISIN Corporation, a leading supplier of automotive technology products employing more than 100,000 people worldwide. Our Values Growth & happiness for our employees and colleagues Inspiration & trust for our customers A sustainable environment for the future Aisin Group Way Be proactive, make changes (take...

  • IT Solution Expert Regulatory

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsTo strengthen our Information Technology team, based in Braine-l'Alleud, Belgium, or Raleigh, North Carolina, US, or UK, we are looking for a talented individual to fill the position of IT Solution Expert Regulatory & QualityAbout The RoleThis role has global responsibility for all IT systems that enable the Regulatory and Quality...

  • Seeking Trilingual Profiles for a Rewarding Role!

    Il y a 2 mois

    Braine-l'Alleud, Belgique BAXTER Temps plein

    **Vantive: A New Company Built On Our Legacy** Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Pharmacovigilance Specialist

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique BAXTER Temps plein

    This is where you save and sustain livesAt 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 outcomes for millions of patients.Baxter's products and therapies are found in almost...

  • Pharmacovigilance Specialist

    il y a 3 semaines

    Braine-l'Alleud, Belgique BAXTER Temps plein

    **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 outcomes for millions of patients. Baxter's products and therapies are found in...

  • Seeking Trilingual Profiles for a Rewarding Role

    il y a 6 jours

    Braine-l'Alleud, Wallonie, Belgique BAXTER Temps plein

    Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care...

  • Labelling Implementation

    il y a 3 semaines

    Braine-l'Alleud, Belgique Jefferson Wells Temps plein

    Location: **Braine l'Alleud** **#24194** **Labelling implementation & partner specialist**: Brabant Wallon - contracting Our partner is looking for a **Labelling implementation & partner specialist** to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. **What are your...