Regulatory Affairs Specialist

As a Junior Regulatory Affairs Specialist, you will be responsible for assisting in the management of regulatory affairs activities related to our biocide products. You will collaborate closely with the regulatory affairs team and other cross-functional departments to ensure compliance with relevant regulations and standards. **Responsibilities**: - Assist...

As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for biocide products. You will work closely with cross-functional teams, regulatory authorities, and external partners to facilitate the registration and approval processes for biocide products in different markets. Your expertise in...

We zijn op zoek naar een ervaren Senior Regulatory Affairs Specialist om ons team te versterken in regio Gent. In deze rol ben je verantwoordelijk voor het coördineren, implementeren en waarborgen van naleving van alle relevante wet - en regelgeving. Als Senior Regulatory Affairs Specialist ben je de expert in je vakgebied en zul je fungeren als interne en...

DeLaval is looking for a **Regulatory Affairs Specialist** to strengthen the Regulatory Affairs team. The position is based at DeLaval NV in Drongen, Belgium, but occasional international travelling might be required. **Purpose of the role and key responsibilities** - Play a key role in the regulatory information flow and follow-up on registration &...

**The job**: We are looking for a Regulatory Affairs Specialist to support the global product stewardship and regulatory affairs Crop Protection team. In close collaboration with business, technology and product management, you give support in protecting the existing portfolio of products and actively engage in projects to extend our growth worldwide. This...

Do you want to be an expert in **medical affairs** - **market access** and **regulatory affairs**? We have a great opportunity to be able to learn and to get an expert in these fields. The great thing about it, is that this mix of RA and Medical affairs or Market access is not that common in the field. This could be the reason why you as an RA professional...

**About the role** The Regulatory Affairs Manager is responsible for managing the lifecycle of the medicines from the preparation of the registration dossier, including the follow-up and finalization of new registrations, the preparation to market access, compilation, submission, and follow-up of variation dossiers in the Benelux. Basically the RA manager...

Ben jij op zoek naar een uitdagende functie waarin je een belangrijke rol speelt bij het waarborgen van de kwaliteit en veiligheid van lekkere zuivelproducten? Ben jij een expert op het gebied van wet - en regelgeving en wil je jouw kennis graag toepassen in een dynamische en internationale omgeving? Dan zijn wij op zoek naar jou! Wat we vragen - Je bent...

Requisition ID - 39 - Job Family 1- Regulatory & PSRM - Country 1- Belgium - Location 1- Hybrid - About us - **Cooper Consumer Health** is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) products with strong brands such as Valdispert, Oenobiol, Excilor, Vitascorbol, Lashyle and...

For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, based in Europe, to support the rapid growth needed for successful commercialization. The role will report into the Global Head of Regulatory Affairs. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs...

For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. PURPOSE OF THE ROLE The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute...

**WHO ARE WE?**: At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 53,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have...

For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, argenx, based in Europe, to support the rapid growth needed for successful commercialization. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs is a key member of the global regulatory team. This role...

The Regulatory Affairs team is expanding and is currently looking for a Regulatory Liaison. Purpose of the position: Assists in global regulatory activities and manages the operational aspects of regulatory filings, and other to health authorities. Supports global regulatory leader(s) in execution of project strategies. Key...

Key Accountabilities and Responsibilities: Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to other territories world-wide. Critical to this role are strong CMC regulatory strategy and...

Elements Advisory helps companies market biocides that are safe for humans and the environment. These products need to comply with the Biocidal Products Regulation (BPR, EU 528/2012). By joining our team, you will learn about regulatory human and environmental safety, an ever-growing market. Our office is Ghent-based. **We are looking for a colleague who...

For the expansion of our Regulatory Affairs team, argenx is looking for a Regulatory Operations Lead, who will lead global regulatory operational activities and manages the operational aspects of eCTD filings and other regulatory filings to Health Authorities. Key Accountabilities/Responsibilities: The position will have the following key...

For the expansion of our Regulatory team, argenx is looking for a Center of Excellence Regulatory Lead who is responsible for:- managing the team of regulatory associates that performs regulatory oversight for the individual studies. Key Accountabilities/Responsibilities: - Maintain an in-depth knowledge of the fast-evolving global clinical trial...

**About the role of QA Specialist** Depending on your level of experience, you collaborate on or lead the management of projects or operational services linked to quality assurance system of various clients (pharma, biotech, medtech), such as: - Deviations, CAPA, Change Control, OOS management; - Supplier/Vendor management; - PQR writing/reviewing; - Audit...

**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...