Lavori attuali relativi a Senior Associate, Early Phase, Regulatory Affairs - Milano - Pfizer
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Milano, Italia Pfizer A tempo pienoSenior Associate, Early Phase, Regulatory AffairsJob SummaryRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolioProvide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST)Lead and implement EU regulatory strategies in agreement with key stakeholders...
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Milano, Italia Pfizer A tempo pienoSenior Associate, Early Phase, Regulatory AffairsJob SummaryRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio.Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).Lead and implement EU regulatory strategies in agreement with key...
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Milano, Italia Pfizer A tempo pienoJob Summary Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio.Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line...
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Regulatory Affairs Professional
4 settimane fa
Milano, Lombardia, Italia Pfizer A tempo pieno**About the Role**Pfizer is seeking a highly skilled Regulatory Affairs Professional to join our team in the Early Phase Oncology department. This role will be responsible for ensuring timely submissions and approvals in the EU region, as well as providing regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).Key...
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Milano, Italia Pfizer, S.A. de C.V A tempo pienoEarly Phase, EU Regulatory Strategy Sr. Associate We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to...
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Early Phase, Eu Regulatory Strategy Sr. Associate
3 settimane fa
Milano, Italia Pfizer, S.A. De C.V A tempo pienoEarly Phase, EU Regulatory Strategy Sr. Associate We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place. To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for...
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Early Phase, Eu Regulatory Strategy Sr. Associate
2 settimane fa
Milano, Italia Pfizer, S.A. De C.V A tempo pienoEarly Phase, EU Regulatory Strategy Sr.Associate We're in relentless pursuit of breakthroughs that change patients' lives.We innovate every day to make the world a healthier place.To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients...
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Early Phase, Eu Regulatory Strategy Sr. Associate
2 settimane fa
Milano, Italia Pfizer, S.A. De C.V A tempo pienoEarly Phase, EU Regulatory Strategy Sr. AssociateWe're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for...
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Early Phase, Eu Regulatory Strategy Sr. Associate
3 settimane fa
Milano, Italia Pfizer A tempo pienoRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio - Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) - Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the...
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Early Phase, Eu Regulatory Strategy Sr. Associate
1 settimana fa
Milano, Italia Pfizer A tempo pienoRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the...
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Early Phase, Eu Regulatory Strategy Sr. Associate
1 settimana fa
Milano, Italia Pfizer A tempo pienoRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST)Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company...
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Early Phase, Eu Regulatory Strategy Sr. Associate
1 settimana fa
Milano, Italia Pfizer A tempo pienoRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the...
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Associate Director, Regulatory Affairs
2 mesi fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....
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Associate Director, Regulatory Affairs
2 mesi fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....
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Associate Director, Regulatory Affairs
2 mesi fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
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Associate Director, Regulatory Affairs
1 mese fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
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Associate Director, Regulatory Affairs
2 mesi fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
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Regulatory Affairs Associate
1 settimana fa
Milano, Italia Norgine A tempo pieno**The Regulatory Affairs Associate is responsible for assisting the Regulatory Affairs team in our Italian affiliate. Sound interesting? Then read on** Ultimately, at Norgine, we look for the following skills and experience in our Regulatory Affairs Associate; - Some experience in the pharmaceutical industry - An awareness of the drug development process -...
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Regulatory Affairs Associate
6 giorni fa
Milano, Italia Norgine A tempo pieno**The Regulatory Affairs Associate is responsible for assisting the Regulatory Affairs team in our Italian affiliate.Sound interesting?Then read on**Ultimately, at Norgine, we look for the following skills and experience in our Regulatory Affairs Associate;- Some experience in the pharmaceutical industry- An awareness of the drug development process-...
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Regulatory Affairs Associate
7 giorni fa
Milano, Italia Sonnedix A tempo pienoTo apply, please submit a CV and Covering Letter explaining how your experience matches the requirements of our position and how your personal motivators and values align to Sonnedix purpose.**Vacancy Name** - Regulatory Affairs Associate - Italy (Milan) **Location** - Milan **Location Country** - Italy **Profile** - The Role: The Regulatory Affairs...
Senior Associate, Early Phase, Regulatory Affairs
2 mesi fa
Senior Associate, Early Phase, Regulatory AffairsJob Summary Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio.Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals.Accountable for timely submissions and approvals in the EU region.Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EU.Job Responsibilities Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned early-stage oncology portfolio.Ensures regulatory contributions achieve the objectives in the strategy, agreed standards, maximizing overall project delivery time and probability of success, and facilitating submission activities.Partners with project teams to ensure required regulatory contributions (CTA, etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.Ensures an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the EU business are championed and communicated.Engages in appropriate activities in order to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.Ensures business compliance and implementation of and adherence to Regulatory standards.Develops and maintains, directly or indirectly, constructive working relationships with Health Authority contacts in the EU region.Organizational Relationship Reports to early phase Oncology EU lead.Works with GRS colleagues and relevant project team(s) members (i.e. Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).Partners with EU colleagues, including GRS-in Country colleagues and Medical colleagues, to provide an EU position.Works directly or indirectly with external contacts in Regulatory Agencies within EU region.Ensures alignment with GRL and early phase Oncology Global Head.Qualification Skills Scientific Degree. A higher degree may be an advantage but is not essential.Proven experience in managing national and/or EU regulatory process and registration aspects of the drug development process, particularly clinical trials experience at least in one country.Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency or working on substantive industry-government collaborations, can be considered.Experience in communicating with major EU regulatory agency(ies), respectively, as well as participating in/leading such interactions, is preferred.Knowledge of drug development practice rules, regulations, and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting CTAs.Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports, and senior manager.Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.
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