Principal Reg Affairs Specialist
3 mesi fa
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Currently we are seeking a Principal Regulatory Affairs Specialist to join our growing Regulatory Affairs department - Regulatory science team. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field.
**Principal Regulatory Affairs Specialist - CTA (Clinical Research Field)**
In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services.
You’ll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as primary point of contact for the sponsors of assigned projects
**The following skills are required to be successful in this position**:
- Experience developing regulatory strategies globally
- Experience and knowledge of bid defence meetings
- Experience leading global regulatory projects
- Client facing experience
**Education and experience**:
- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the global clinical trials landscape
- Proven project management experience, and experience performing effectively in a client facing role
**Knowledge, Skills and Abilities**:
- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Excellent negotiation skills
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
- Excellent analytical, investigative and problem-solving skills
- Understanding of budgeting and forecasting
**What we offer**:
At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ coll
-
Principal Reg Affairs Specialist
4 mesi fa
Milano, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Sr Reg Affairs Specialist
3 mesi fa
Milano, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Legal Affairs Specialist
1 mese fa
Milano, Italia Profili & Carriere S.R.L. A tempo pienoGruppo internazionale settore industrial property management ricerca LEGAL AFFAIRS SPECIALIST.Attività:Gestione della contrattualistica attiva;evidenziare le criticità ed il rispetto delle procedure aziendali di gruppo e delle indicazioni della direzione;revisione contratti in essere con clienti;stesura ed analisi contrattuale.Laurea in...
-
Regulatory Affairs Specialist
3 giorni fa
Milano, Lombardia, Italia Lights on Women (LoW) A tempo pienoJob Title: Regulatory Affairs SpecialistAt Lights on Women (LoW), we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will play a crucial role in ensuring our compliance with EU regulatory requirements and supporting our business functions in the gas distribution market.Key...
-
Regulatory Affairs Specialist
3 giorni fa
Milano, Lombardia, Italia Lights on Women (LoW) A tempo pieno{"title": "Regulatory Affairs Specialist", "content": "About the Role:Lights on Women (LoW) is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will play a crucial role in ensuring our compliance with EU regulatory requirements and supporting our business functions in the assessment of...
-
Legal Affairs Specialist
3 mesi fa
Milano, Italia Imprendere A tempo pienoGruppo internazionale settore industrial property management ricerca LEGAL AFFAIRS SPECIALIST. Attività: - Gestione della contrattualistica attiva; - evidenziare le criticità ed il rispetto delle procedure aziendali di gruppo e delle indicazioni della direzione; - revisione contratti in essere con clienti; - stesura ed analisi...
-
Regulatory Affairs Specialist
3 mesi fa
Milano, Italia Italgas A tempo pieno**Gruppo Italgas**: Siamo il primo operatore in Italia nella distribuzione del gas e il terzo in Europa. Siamo presenti anche in Grecia attraverso Depa Infrastructure, principale leader ellenico del settore. Oltre al gas, ci occupiamo anche di acqua in Campania e, grazie a Geoside, operiamo nel mercato dell’efficienza energetica, con un’offerta integrata...
-
Regulatory Affairs Specialist
2 settimane fa
Milano, Lombardia, Italia Page Personnel A tempo pienoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our regulatory team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.Main ResponsibilitiesManage and prepare regulatory dossiers (CTD)...
-
Regulatory Affairs Specialist
2 settimane fa
Milano, Lombardia, Italia Page Personnel A tempo pienoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our regulatory team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.Main ResponsibilitiesManage and prepare regulatory dossiers (CTD)...
-
Regulatory Affairs Specialist
3 giorni fa
Milano, Lombardia, Italia CooperCompanies A tempo pienoJob Title: Senior RA SpecialistCooperVision is a leading manufacturer of soft contact lenses with a global presence. We're seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.About the Role:As a Senior RA Specialist, you will provide regulatory support, guidance, and direction to products from concept to launch. You will follow the...
-
Reg Affairs Associate Director
3 mesi fa
Milano, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Regulatory Affairs Specialist Eu
3 mesi fa
Milano, Italia Clinglobal Group A tempo pieno**Regulatory Affairs Specialist - European Union** Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a** Regulatory Affairs Specialist** based in the EU to join our growing Regulatory Affairs team at Clinglobal. This position offers the opportunity to work...
-
Regulatory Affairs Specialist
1 mese fa
Milano, Italia Italgas Spa A tempo pienoSeleziona la frequenza (in giorni) di ricezione di un avviso:Milano, ITGruppo Italgas Siamo il primo operatore in Italia nella distribuzione del gas e il terzo in Europa. Siamo presenti anche in Grecia attraverso Depa Infrastructure, principale leader ellenico del settore. Oltre al gas, ci occupiamo anche di acqua in Campania e, grazie a Geoside, operiamo...
-
Regulatory Affairs Specialist
3 mesi fa
Milano, Italia Italgas Spa A tempo pienoSeleziona la frequenza (in giorni) di ricezione di un avviso: Milano, IT Gruppo ItalgasSiamo il primo operatore in Italia nella distribuzione del gas e il terzo in Europa. Siamo presenti anche in Grecia attraverso Depa Infrastructure, principale leader ellenico del settore. Oltre al gas, ci occupiamo anche di acqua in Campania e, grazie a Geoside, operiamo...
-
Legal Affairs Specialist
3 mesi fa
Milano Est, Italia Imprendere A tempo pienoGruppo internazionale settore industrial property management ricerca LEGAL AFFAIRS SPECIALIST. Attività: - Gestione della contrattualistica attiva; - evidenziare le criticità ed il rispetto delle procedure aziendali di gruppo e delle indicazioni della direzione; - revisione contratti in essere con clienti; - stesura ed analisi...
-
Corporate Affairs Specialist
1 settimana fa
Milano, Provincia di Milano, Italia Risorse SpA A tempo pienoRisorse Professional , società specializzata nella Ricerca e Selezione di profili Middle e Senior Management, per nota Compagnia Assicurativa quotata, ricerca: Corporate Affairs Specialist - Segreteria Societaria La Risorsa sarà inserita nella direzione Corporate A
-
Regulatory Affairs Specialist
2 settimane fa
Milano, Lombardia, Italia PharmaLex A tempo pienoJob Title: Regulatory Affairs Specialist - LabellingPharmaLex is seeking a highly skilled Regulatory Affairs Specialist - Labelling to join our team. In this role, you will be responsible for ensuring the accuracy and compliance of labelling documentation for pharmaceutical products.Key Responsibilities:Participate in the preparation and revision of...
-
Regulatory Affairs Specialist
2 settimane fa
Milano, Lombardia, Italia PharmaLex A tempo pienoJob Title: Regulatory Affairs Specialist - LabellingPharmaLex is seeking a highly skilled Regulatory Affairs Specialist - Labelling to join our team. In this role, you will be responsible for ensuring the accuracy and compliance of labelling documentation for pharmaceutical products.Key Responsibilities:Participate in the preparation and revision of...
-
Regulatory Affairs Specialist
3 mesi fa
Provincia di Milano, Lombardia, Italia Instrumentation Laboratory spa A tempo pienoFor our Clinical Chemistry Strategic Business Unit, based in Milan (Italy), we are looking for a: **Regulatory Affairs Specialist - Maternity Leave**: The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market. The main accountabilities of the Regulatory Affairs Specialist are: Support registrations, understand the local...
-
Network, Regulatory
3 giorni fa
Milano, Italia Groupe Iliad A tempo pienoIl Network, Regulatory & Wholesale Affairs Specialist – Legal Counsel per il Gruppo Iliad Italia (Iliad) è un componente attivo del Legal Team di Iliad.In tale qualità, il Network, Regulatory & Wholesale Affairs Specialist, riportando al Lead di riferimento e in coordinamento con quest'ultimo, anche seguendo le indicazioni del General Counsel e in...