Director of Regulatory Development and Strategy
hace 6 meses
**Director of Regulatory Development and Strategy**
**UK or EU based (Hybrid working with some travel)**
**Salary**: Competitive + Benefits + Bonus
If you are a dynamic regulatory leader with expert technical and tactical experience in regulatory strategy in the UK, EU and internationally then we want to hear from you.
Join us to help improve peoples' lives and make healthcare better for everyone
**Why Pharmanovia?**
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.
**Our core behaviours are**:
- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- We value our heritage and foster an entrepreneurial spirit.
- We reinvest in our future - in our products, our brands, and our people.
- We give back to our communities.
Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.
We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.
Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.
**About the role**:
***
The Director of Regulatory Development and Strategy reports to the Senior director of product development and works closely with the clinical and medical team, as well as project leaders, product development teams and with the relevant functions throughout the organization.
This is a key role which acts at the interface between the company and the regulatory authorities, through the entire life cycle of the medication, from early development, to commercialization across all our regions.
**Main responsibilities & duties**:
- With the project lead, build the regulatory strategy and plans for the projects in the pipeline with focus on clinical and non-clinical aspects of the dossier.
- Provide leadership and act as SME in implementing registration strategy across relevant groups, including Clinical Development, Preclinical Development, Marketing and CMC.
- Lead and work closely with relevant clinical development, operations and research personnel to ensure regulatory compliance and consistency with regulatory registration strategy.
- Understand the need of clinical study as per requirements of regulatory agencies.
- Support the build of global clinical development strategy based on correct interpretation of regulatory requirements.
- Review and Input into clinical study protocols and reports to support the intended indications in line with regulatory requirements.
- Responsibility of authoring and reviewing the clinical sections of the dossier (modules 5) for regulatory submissions.
- Manage interactions and build positive relationships with all relevant Health Authorities and service providers to facilitate timely and compliant submissions and approvals.
- Advise senior management on regulatory and clinical strategy pathways and options for successful developments.
- With the relevant functions, input into the preparation of the clinical aspect of pre-submission /paediatric investigation/ scientific advice briefing packages.
- Design the regulatory input on clinical sections of clinical trial protocols and strategy for paediatric investigation plans and/or waivers.
- Building the orphan drug submission strategies.
- Literature search and building the scientific clinical rationales to support the strategies.
- Provide support in post-approval clinical commitments (Registry, Phase IV Studies, RWE etc.) and digital projects with regulatory strategy for development.
- Analyse and interpret scientific and clinical data critically to support regulatory submissions and strategies.
- With the medical director, reviews material for communications with external stakeholders, including, promotional materials, press-releases, study ads and relevant media for regulatory compliance
- With the quality lead ascertains the compliance of production with ICH-GCP guidelines and other relevant specifications and regulatory guidan
-
Associate Director of Translational Regulatory
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona (on-site)** Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our...
-
Barcelona, España Astrazeneca A tiempo completo.The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs.You will be...
-
Barcelona, España Astrazeneca A tiempo completo.The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs. You will be...
-
Barcelona, España Astrazeneca A tiempo completo.Associate Director of Translational Regulatory Science Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients....
-
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona (on-site)Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline...
-
Barcelona, España Astrazeneca A tiempo completoThe Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs.You will be...
-
Barcelona, España Astrazeneca A tiempo completoAssociate Director of Translational Regulatory ScienceWithin Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We...
-
Barcelona, España Astrazeneca A tiempo completoAssociate Director of Translational Regulatory Science Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We...
-
Barcelona, España Astrazeneca A tiempo completoAssociate Director of Translational Regulatory ScienceWithin Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We...
-
Barcelona, España Astrazeneca A tiempo completoLocation: Barcelona (on-site)Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline...
-
Labelling Strategy Director
hace 6 meses
Barcelona, España AstraZeneca A tiempo completoThe Labelling Strategy Director provides regulatory labelling expertise and guidance, typically for more complex drug projects and across a Therapy Area (TA)/Disease Area (DA), to Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and cross functional Product Labelling Teams (PLT). The Labelling Strategy Director...
-
Barcelona, España AstraZeneca A tiempo completoAssociate Director of Translational Regulatory Science Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We...
-
Director, Quality and Regulatory
hace 3 meses
Barcelona, España Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office We are currently seeking a highly motivated and experienced Director, Quality and Regulatory to join our Engineering team at Thermo Fisher Scientific Inc. As a world-class leader in the industry, Thermo Fisher Scientific Inc. provides exceptional opportunities for growth and...
-
Director, Clinical Regulatory Writing
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.Job DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team...
-
Regulatory Affairs Director
hace 6 meses
Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology...
-
Senior Director/director, Global Regulatory Affairs
hace 5 meses
Barcelona, España AstraZeneca A tiempo completoDo you have leadership skills and an in depth knowledge within **Regulatory Affairs? **Do you want to work on **innovative projects** of importance for our early Respiratory and Immunology portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win,...
-
Director, Clinical Regulatory Writing
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.Job DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team...
-
Senior Regulatory Affairs Director
hace 3 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completo.At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional...
-
Director, Clinical Regulatory Writing
hace 2 meses
Barcelona, España Astrazeneca Gmbh A tiempo completoJob DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important...
-
Director, Clinical Regulatory Writing
hace 2 meses
Barcelona, España Astrazeneca Gmbh A tiempo completoJob DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important...
