Senior Regulatory Affairs Manager
hace 1 mes
**Requisition Number**
**7297**
**Employment Type***:
**Regular**
**Who we are**
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
In this role, The Senior Manager, Regulatory Affairs provides project representation and input to projects awarded for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department.
**What you will do**
- Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
- Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
- Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
- Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
**What you will bring to the role**
- Clearly, proven leadership and organizational management skills are essential attributes
- Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Excellent written and verbal communication skills to clearly and concisely present information
- Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
**Your experience**
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
- Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
- Minimum 7 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
- Proficient in cross-cultural communication and proficient in both spoken and written English
**Why Worldwide**
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
-
Barcelona provincia, España Morgan Philips Executive Search A tiempo completoAs part of the Global Regulatory Affairs Team, we offer you an exciting and responsible task in a globally operating functional area. We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them, as well as to develop professionally. If you are also enthusiastic about our meaningful product portfolio, we...
-
Senior Internal Auditor
hace 4 semanas
Ourense provincia, España Five One Recruitment A tiempo completo**Responsibilities**: Execute the internal audit process under the direction of the Internal Audit Manager. Main responsibilities are: - Assess whether systems of internal controls, processes and procedures are adequate to manage risks, provide accurate financial reports and to safeguard corporate assets. - Check that Group corporate and regional policies...
-
Technician Regulatory Affairs
hace 1 mes
Yunquera de Henares, Guadalajara provincia, España Grupo Crit A tiempo completo**Descripción**: Desde Grupo Crit nos encontramos en búsqueda de un Técnico de Asuntos Regulatorios para una gran empresa ubicada en Yunquera de Henares, Guadalajara. Formación, conocimientos y experiência necesarios: Graduado en química / Ingeniería Química / Farmacia. Máster en cosmética. Elaboración Fichas de Datos de...
-
Castellón provincia, España Noa's Grupo A tiempo completoEn Noa's Talent Recruitment, seleccionamos Senior Area Manager Centroamérica para importante empresa del sector cerámico situada en la provincia de Castellón. **Requisitos**: - Mínimo formación de Grado Medio o Superior. - Imprescindible experiência dilatada en el puesto como Area Manager en el sector cerámico gestionando mercado centroamericano. -...
-
Senior Area Manager Francia
hace 7 días
Castellón provincia, España Noa's Grupo A tiempo completoEn Noa's Talent Recruitment, seleccionamos Senior Area Manager Francia para importante empresa del sector cerámico situada en la provincia de Castellón. **Requisitos**: - Mínimo formación de Grado Medio o Superior. - Imprescindible experiência dilatada en el puesto como Area Manager en el sector cerámico gestionando mercado francés. - Posibilidad de...
-
Offshore Installation Manager
hace 1 mes
Alicante provincia, España Kinekta A tiempo completoKinekta are currently working with one of the world’s leading companies in renewable power generation who are hiring for an **Offshore Installation Manager - Cables (senior)** to join their offshore installation and logistics team to support global offshore wind projects at all lifecycle stages. Offshore Wind is a constantly evolving industry and within...
-
Alicante provincia, España Kinekta A tiempo completoKinekta are currently working with one of the world’s leading companies in renewable power generation who are hiring for a **Transport & Installation Manager - WTG (senior)** to join their offshore installation and logistics team to support global offshore wind projects at all lifecycle stages. Offshore Wind is a constantly evolving industry and within...
-
Senior Qc/welding Inspector
hace 1 mes
Cádiz provincia, España IKM Consultants A tiempo completo**Responsibilities**: - Work in a proactive manner by setting the priorities of HSE first - Participate in pre-inspections meetings and all other related to QC and fabrication meetings. - Preform continuous quality surveillance and inspections, to verify and confirm that safety, quality, and quantity of the work, is in line with the contract specifications,...
-
Field Market Access Manager
hace 1 mes
Tres Cantos, Madrid provincia, España Incyte Corporation A tiempo completoOverview: **Summary** The Field Market Access Manager is responsible for establishing and implementing the regional/account market access strategy in Iberia for current and future medicinal products of Incyte in his/her areas of responsibility under the supervision of the Iberia Market Access Director and in alignment with the EU VAP strategy. A very...
-
Maintenance Senior Manager
hace 1 día
Valls, Tarragona provincia, España Essity A tiempo completo**About the role** We are looking for an experienced Senior Maintenance Manager. Must have extensive experience with Preventative and Predictive Maintenance and a strong background in Reliability Maintenance principles. Key activities for this position include leading the maintenance and reliability team, maintenance of production equipment and spare parts...
-
Divisional Planning Manager
hace 1 mes
Granollers, Barcelona provincia, España coty A tiempo completo**ROLE**: Divisional Planning Manager **REPORTS TO**: Global Demand Planning Prestige Director **LOCATION**: BCN hub Purpose In close collaboration with NY & Paris Global Supply Teams, the Divisional Planning Manager will take over a cross-functional responsibility driving a new strategic segment with Marc Jacob Beauty from a Global lifecycle and Demand...
-
Senior Operations Manager
hace 1 mes
Barberà del Vallès, Barcelona provincia, España Amazon Road Transport Spain, S.L.U. A tiempo completoA degree Relevant experience in manufacturing, production, distribution logistics environments, retail, or grocery in a management role Relevant experience of working within a complex stakeholder structure Advanced proficiency in verbal and written English and upper intermediate proficiency in the local language Our operations help everything to come...
-
Cádiz provincia, España Head Energy A tiempo completoWork in a proactive manner by setting the priorities of HSE first - Participate in pre-inspections meetings and all other related to QC and fabrication meetings. - Preform continuous quality surveillance and inspections, to verify and confirm that safety, quality, - and quantity of the work, is in line with the contract specifications, design drawings and...
-
Senior Qc
hace 7 días
Cádiz provincia, España Techconsult AS A tiempo completoTechconsult is the link between jobs and professionals. For one of our customers we are now looking for a Senior QC / Welding inspector **Job responsibilities**: - Work in a proactive manner by setting the priorities of HSE first - Participate in pre-inspections meetings and all other related to QC and fabrication meetings. - Preform continuous quality...
-
Content Manager
hace 1 mes
Mallorca, Illes Balears provincia, España Hotelbeds A tiempo completoHotelbeds is the world’s leading technology partner, connecting and empowering the world of travel. We’re game-changers, disruptors, the people who bring together local and global brands in accommodation, transport, activities and payments through our network of 300,000 hotels worldwide, 60,000 hard to reach high value clients such as tour operators,...
-
Transport & Installation Manager
hace 1 mes
Alicante provincia, España Kinekta A tiempo completoKinekta are currently working with one of the world’s leading companies in renewable power generation who are currently hiring for a Senior level **Transports & Installation (T&I) Manager** to support their global offshore wind project portfolio, across all lifecycle stages. Offshore Wind is a constantly evolving industry and within this role you will be...
-
Payment Risks Global Senior Manager
hace 1 mes
Mallorca, Illes Balears provincia, España Hotelbeds A tiempo completoHotelbeds is the world’s leading technology partner, connecting and empowering the world of travel. We’re game-changers, disruptors, the people who bring together local and global brands in accommodation, transport, activities and payments through our network of 300,000 hotels worldwide, 60,000 hard to reach high value clients such as tour operators,...
-
Ppm - Procurement Product Manager
hace 4 semanas
Tres Cantos, Madrid provincia, España Thales A tiempo completoLocation: Madrid Tres Cantos, Spain A Joint Venture between Thales (67%) and Leonardo (33%), Thales Alenia Space is a global space manufacturer delivering, for more than 40 years, high-tech solutions for telecommunications, navigation, Earth Observation, environmental management, exploration, science and orbital infrastructures. Thanks to our diversity of...
-
Barcelona provincia, España TOP MANAGEMENT GROUP A tiempo completo**QUI SOMMES-NOUS ?** Filiale du Groupe Top Management, Top Management Espagne est installée à Barcelone et à Madrid. Nous sommes une société de 70 personnes, dont le siège est basé à Barcelone. Spécialistes de la construction de bâtiments industriels, logistiques et tertiaires, nous sommes une ingénierie agissant principalement en tant...
-
Medical Science Liaison
hace 1 mes
Unión, Murcia provincia, España Argenx A tiempo completoThe Medical Research Liaison (MSL) is a field-based expert on argenx’s scientific data, products and trials, responsible for engagement with medical stakeholders at centers across the region but also with patient groups, policy makers and government payors. _You are located in one of these regions: _ - Sicilia, Puglia, Basilicata or Calabria_- The MSL...