Zonal Regulatory Associate
vor 2 Monaten
**Description**:** Purpose**:
Provides registration support to a Zonal Regulatory Leader (ZTL) for actives and products at EMEA levelfor active ingredient registration (EU registration and renewal of registrations) and for formulationregistration projects. Provides logístical and administrative support to collate and manage regulatorydossiers. Provides leadership for producing electronic dossiers (IUCLID, CDRom, CADDY) and facilitatingthe use of Global Dossier Assembler.
**Interacts With**:
- ZRL and members of the Regulatory Team(s), whether permanent or ad-hoc: Country RegulatoryManagers (CRMs), Subject Matter Experts (SMEs), Food Chain Specialists, data managers andexternal CROss,
- CORE
**Key Responsibilities**:
- Support ZRL in clearly defined, delegated tasks and activities according to need, for activesubstance or PPP authorization projects, actively using the l tools and data managementsystems for the regulatory function. For example:
- Participation to all relevant team (SME, network, manufacturing) meetings, with taskforce
- Collation and review of residue data with SMEs for development and preparation of EUMRL or CODEX packages
- Implementation of defined parts of the regulatory strategy
- Co-ordinate discussions between CRMs and SMEs on identification of cGAP/riskenvelopes
- Working with CRMs to document agreed supported uses and develop registrationresource requirements
- Liaison with SMEs to plan and agree schedule for dossier production
- Liaison with external contractors for regulatory activities such as dossier preparationoInformation gathering for re-registration, line extensions or formulation changes
- Provide information for Emergency Use Permits
- Preparation of Documents in the active substance or PPP dossier owned by Registration(e.g. GAP, authorized uses)
- Provide logístical and administrative support for active substance or PPP submissions. Forexample:
- dossier collation and editing
- generation of reference lists
- Use of Global Dossier Assembler
- Liaison with CORE
- Maintenance of documentations (databases and file shares)
- Archiving of appropriate documents in NetDocuments
- Support for meeting EU transparency requirements: Notification of Studies, sanitizationof documents, first point of contact for liaising with CROs on IUCLID
LI-SD1 #LI-Onsite
**Qualifications**:** Qualifications and Skills**:
- Educated to at least BSc level in a biological science, preferably with an additional higher level scientific degree.
- Some regulatory knowledge desirable, but full training will be provided.
- Good communication skills: proactivity, quick learner, self-motivated, attention to detail and well-organised - but also must be an effective team player. Highly proficient in MS office (especially Word and Excel).
- Good knowledge of written and spoken English. Another language is a plus.
-
Associate Regulatory Affairs
vor 1 Monat
Munich, Deutschland Daiichi-Sankyo Europe Vollzeit**Passion for Innovation. Compassion for Patients.**: ***Associate Regulatory Affairs - EU Regulatory Procedural Management (M/F/x)***: - limited until 31.10.2024 -**: **The position**: Provide support for EU Regulatory Procedural Management for assigned projects including all pre - and post-authorisation activities ensuring a smooth run of regulatory...
-
Emea Chemical Legislation Reach Regulatory Associate
vor 2 Wochen
Munich, Deutschland Corteva Vollzeit**Description**: Following the merger of the Dow Chemical Company and DuPont, we are strengthening Corteva Agriscience, the Agricultural Division of DowDuPont. Towards that, the Regulatory and Stewardship (RAS) function is recruiting a professional as an EMEA REACH & Chemical Legislation Regulatory Associate for both our crop protection and seeds platforms...
-
Regulatory Affairs Associate
vor 2 Monaten
Munich, Deutschland OPTARES Gmbh & Co. KG Vollzeit[5840] Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong...
-
Regulatory Submission Associate
Vor 4 Tagen
Munich, Deutschland Fortrea - Organic VollzeitAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Regulatory Affairs Associate
vor 2 Monaten
Munich, Deutschland Progressive Recruitment NL VollzeitFür ein biopharmazeutisches Unternehmen in München suchen wir zum nächstmöglichen Zeitpunkt eine/n **Regulatory Affairs Associate (m/w/d)** Supports the activities of the affiliate's Regulatory Affairs team to ensure that the company complies with country's applicable legislations and regulations pertaining to the portfolio (at all stages of the...
-
Country Regulatory Team Leader
vor 1 Woche
Munich, Deutschland Corteva Vollzeit**Description**: Corteva Agriscience, the world's first dedicated agriculture start-up, serves to enrich the lives of those who produce and those who consume, ensuring progress for generations to come. Our employees fulfill this purpose everyday by building/participating in an inclusive culture where we encourage each other to stay curious, think...
-
Senior Associate
vor 1 Monat
Munich, Deutschland H&P Executive Search VollzeitSenior Associate - EnergyWe are pleased to announce we are actively recruiting for a Associate or Senior Associate at a highly regarded, Tier 2 Energy German law firm. They were named in Legal 500’s ‘Top Tier 2023’ Law firms.As they expand their energy sector, they are looking for German qualified lawyers specialising in either the transactional energy...
-
Associate/senior Associate Compliance
vor 1 Woche
Munich, Deutschland Macquarie Group VollzeitWe are looking for a Compliance Associate/Senior Associate, to be based in Munich who will support the compliance coverage of Macquarie Asset Management's Real Estate business, in Germany and Luxembourg and will act as Deputy Compliance Officer/MLRO in Germany. It is a wide-ranging role with a lot of responsibility, focused on strengthening and improving our...
-
Associate/senior Associate Compliance
vor 1 Woche
Munich, Deutschland Macquarie Group Limited VollzeitWe are looking for a Compliance Associate/Senior Associate, to be based in Munich who will support the compliance coverage of Macquarie Asset Management’s Real Estate business, in Germany and Luxembourg and will act as Deputy Compliance Officer/MLRO in Germany. It is a wide-ranging role with a lot of responsibility, focused on strengthening and improving...
-
Associate Director Process Excellence
vor 1 Monat
Munich, Deutschland Novartis Vollzeit2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both...
-
Associate Director Process Excellence
vor 2 Monaten
Munich, Deutschland Sandoz VollzeitJob ID- 378190BR- Jul 05, 2023- Germany**Job Description**: - 2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz,...
-
Associate Director Cmc
vor 1 Tag
Munich, Deutschland Meet Recruitment Vollzeit85000 EUR - 85000 EUR - Munich, Germany - Permanent - Meet partner today with a mid-size and growing biotech who are dedicated to the development of novel therapeutics against acute and chronic diseases. They are stepping now from drug development into a commercial stage and are to build up a CMC department internally for the exciting upcoming times. Right...
-
Regulatory Affairs Specialist
vor 1 Woche
Munich, Deutschland Beckman Coulter Diagnostics Vollzeit**Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...
-
Qm Associate
vor 2 Wochen
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...
-
Qm Associate
vor 1 Woche
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...
-
Rechtsanwalt Als Senior Associate
vor 1 Monat
Munich, Deutschland Rexlegal Vollzeit**FIRMENPROFIL** Unser Mandant ist eine erfolgreiche internationale Sozietät mit global mehr als 500 Berufsträgern. Deutschlandweit arbeiten über 100 Anwälte an 3 Standorten für unseren Kunden und beraten Mandanten unterschiedlicher Rechtsformen und Größen bei Ihrem Tagesgeschäft. Für den Ausbau der Praxisgruppe Public Law & Regulatory, suchen wir...
-
Country Regulatory Team Leader
vor 4 Wochen
Munich, Deutschland Corteva Vollzeit**Description**:** GROWING WHAT MATTERS STARTS WITH YOU** Corteva Agriscience is the global pure-play agriculture company that provides farmers around the world with the most complete portfolio in the industry - including a balanced and diverse mix of seed, crop protection and digital solutions, serves to enrich the lives of those who produce and those who...
-
Pta / Cta - Quereinstieg in Regulatory Affairs Als
vor 2 Monaten
Munich, Deutschland Salus Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG Vollzeit**PTA / CTA - Quereinstieg in Regulatory Affairs als Associate in Teilzeit (m/w/d)** - Wir sorgen mit viel Leidenschaft und Engagement dafür, dass unsere Produkte weltweit für unsere Kund:innen zugänglich sind. Wir sind der direkte Ansprechpartner für unsere Exportabteilung, Vertriebspartner und Behörden bei zulassungsrelevanten & regulatorischen...
-
Clinical Research Associate 2
vor 2 Monaten
Munich, Deutschland Veranex, Inc. VollzeitVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Regulatory Team Leader
vor 3 Wochen
Munich, Deutschland Corteva Agriscience VollzeitDescription GROWING WHAT MATTERS STARTS WITH YOU Corteva Agriscience™ is the global pure-play agriculture company that provides farmers around the world with the most complete portfolio in the industry – including a balanced and diverse mix of seed, crop protection and digital solutions, serves to enrich the lives of those who produce and those...
