Global Regulatory Affairs Strategist
hace 1 semana
Parexel's Global Regulatory Acceleration Initiative
We are seeking an experienced Regulatory Affairs professional to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets.
This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI), emerging markets, and non-EU markets.
About the Role:
- Develop and implement global regulatory strategies for simultaneous marketing authorisation submissions.
- Identify risks and mitigations to protect business interests and maintain timelines.
- Lead detailed preparation of regulatory plans for individual country filings.
- Lead global filing teams in generating country-specific datasets and updating core documentation.
- Lead adaptation of core dossier contents for country submissions.
- Coordinate filing teams for RTQ generation, provide strategic guidance to the global filing teams to address regulators' questions and guide the team to prepare high-quality responses.
- Set up global filing team meetings, draft responses, coordinate reviews and approvals.
- Suggest and coordinate innovative regulatory procedures to increase acceleration opportunities.
- Work closely with local and regional regulatory leads on all aspects of marketing review and approvals.
- Manage routine MA maintenance activities as required.
Qualifications and Experience:
- University degree in a life science industry.
- 8-15 years of relevant regulatory affairs experience.
- Extensive experience in preparing global filing plans for markets worldwide, and awareness of regulatory frameworks in all major markets globally.
- Strong leadership skills and motivated, to support senior filing teams through marketing applications, overarching CMC, Clinical and Nonclinical.
- Familiarity with CPPs and timing for filings in various markets.
- Proficiency in Veeva Vault and other regulatory systems.
- Excellent communication and organisational skills.
- Experience working within a regulatory matrix team in the pharmaceutical industry.
- Fluent in English, written and spoken.
Salary: The estimated salary for this role is £80,000 - £110,000 per annum, depending on experience.
About Parexel:
Parexel is a leading clinical research organisation dedicated to helping clients accelerate time-to-market for new and existing treatments. With a global presence, we offer comprehensive solutions across the entire product development lifecycle.
-
Regulatory Affairs Expert
hace 4 semanas
Madrid, Madrid, España Sobi Group A tiempo completoKey Responsibilities and Accountabilities:Global Regulatory LeadershipThe Global Regulatory Affairs Lead provides global regulatory leadership of assigned programs, developing global regulatory strategies, including risk assessment and mitigation strategies. This role chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s) and is the...
-
Regulatory Affairs Strategy Specialist
hace 1 semana
Madrid, Madrid, España Galderma A tiempo completoGalderma: A Pioneer in DermatologyWe are Galderma, a category leader in dermatology with a legacy that spans decades. Our innovative, science-based portfolio of premium brands and services addresses the full spectrum of the dermatology market through injectable aesthetics, dermo-cosmetics, and therapeutic dermatology.Unlock Your Potential with UsAt Galderma,...
-
Global Regulatory Affairs Lead
hace 1 mes
Madrid, Madrid, España Sobi - Swedish Orphan Biovitrum AB (publ) A tiempo completoJob DescriptionSobi is a global biopharmaceutical company dedicated to rare diseases. We are seeking a highly skilled Global Regulatory Affairs Lead to join our team.Key Responsibilities:Provide global regulatory leadership for assigned programs, developing strategies and risk assessments.Chair the Global Regulatory Team and attend critical regulatory agency...
-
Regulatory Affairs Manager
hace 2 semanas
Madrid, Madrid, España TRIUM Clinical Consulting NV A tiempo completoAbout the RoleWe are seeking a highly experienced Senior Regulatory Affairs Officer to join our team at QbD Group in Spain. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with pharmaceutical legislation and regulations.With a strong background in regulatory affairs, you will have expertise in ICH...
-
Regulatory Affairs Expert
hace 1 mes
Madrid, Madrid, España Parexel A tiempo completoUnlock Your Potential in Regulatory AffairsWe are seeking a highly experienced Senior Regulatory Affairs Manager/Consultant to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for managing client relationships, developing regulatory strategies, and ensuring compliance with EU guidelines.Key...
-
Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Oatly A tiempo completoOatly, the original oatmilk company, is expanding its presence in North America and seeks a highly skilled Regulatory Affairs Manager to join our team. As the leader of our US-based regulatory affairs function, you will provide expert guidance on food law and compliance matters.About the Role:This role involves leading the Oatly North America Regulatory...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Ergomed A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Ergomed, a leading global clinical research organization. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.
-
Regulatory Affairs Specialist
hace 1 mes
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. This role ensures timely preparation of well-organized, quality regulatory submissions in compliance with...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Ventos A tiempo completoRegulatory Affairs Specialist Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ventós Group in Sant Just Desvern, Barcelona. As a Regulatory Affairs Specialist, you will play a key role in maintaining our product database, collaborating with suppliers to homologate new products, preparing technical documentation, and...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionWe are seeking a highly skilled Regulatory Manager to join our team at Precision for Medicine (CRO). The successful candidate will provide regulatory strategy and development guidance for optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Johnson & Johnson Consumer A tiempo completoRegulatory Affairs InternWe are currently recruiting for a Regulatory Affairs intern at Kenvue. As a member of our global team, you will contribute to the development and implementation of regulatory strategies for our products. Your responsibilities will include coordinating and compiling new drug applications, cosmetics, and medical devices for submission...
-
Regulatory Affairs Professional
hace 2 semanas
Madrid, Madrid, España Johnson And Johnson A tiempo completoRegulatory Affairs SpecialistJohnson and Johnson is seeking a skilled Regulatory Affairs Specialist to join our team in Madrid. This role offers a hybrid working model and is an exciting opportunity to contribute to our company's mission to build a world where complex diseases are prevented, treated, and cured.Key ResponsibilitiesSupport the growth of our...
-
Regulatory Affairs Specialist
hace 1 mes
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Iqvia A tiempo completoRegulatory Affairs Role OverviewAs a Regulatory Affairs Specialist at IQVIA, you will play a critical role in supporting clinical trial and marketing authorization activities for both internal and external clients. Your expertise will be instrumental in preparing and reviewing regulatory submissions to ensure compliance with regulatory requirements.Key...
-
Global Medical Affairs Strategist
hace 4 semanas
Madrid, Madrid, España Empresa Reconocida A tiempo completoAt Empresa Reconocida, we believe that healthcare is a vital component of our existence. Our strength in medical innovation empowers us to create a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in MedTech and Innovative Medicine, we are...
-
Madrid, Madrid, España Parexel A tiempo completoUnlocking Global Potential At Parexel, we're committed to accelerating the time to market for our clients' late-stage phase III assets. To achieve this ambitious goal, we're seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative. As a key member of our global regulatory team,...
-
Regulatory Affairs Specialist
hace 3 semanas
Madrid, Madrid, España Kenvue A tiempo completoRegulatory Affairs InternAt Kenvue, we are committed to delivering high-quality products that meet the highest standards of safety and efficacy. As a Regulatory Affairs Intern, you will play a critical role in ensuring compliance with regulatory requirements and maintaining our competitive edge in the market.Key Responsibilities:Regulatory Affairs:...
-
Clinical Strategy Director
hace 1 semana
Madrid, Madrid, España STRAGO A tiempo completoSTRAGO Healthcare is a leading global consultancy that provides top-tier talent services to major Healthcare and Life Sciences organizations worldwide.We are seeking an experienced Clinical Strategy Director - Regulatory Affairs to provide expert strategic advice on clinical and regulatory matters for global drug development projects. In this role, you will...
-
Regulatory Affairs Manager
hace 4 semanas
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoAbout the Role:This position is responsible for providing regulatory guidance throughout the clinical development life cycle, compiling and reviewing applications to Regulatory Authorities, and developing documents intended for submission to ensure compliance with regulatory standards.Key Responsibilities:Provide regulatory strategy and development guidance...
-
Senior Regulatory Affairs Director
hace 4 semanas
Madrid, Madrid, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs Medical Device Lifecycle ManagementAt Cpl Healthcare, we are seeking an experienced Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join our Pharmaceutical team.This key role will be responsible for the strategic lifecycle management of our Medical Device portfolio, ensuring...