Senior Manager, Regulatory Sciences
5 months ago
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Responsibilities:
Independently leaddiscreet client projects (as assigned),and lead project teams through all project phases to ensure efficient project executionand contribute to larger projects.
As required, author global nonclinical/clinical aspects of regulatory documentation including environmental risk assessments, development plans, briefing books, orphan designations, paediatric investigation plans, marketing authorisation applications, contributing to gap analyses and regulatory strategies.
Project Management of assigned projects in accordance with internal procedures – including approval of time entry and invoicing, budget monitoring, client liaison and service growth.
Provide expert guidance and technical expertise, manage complex tasks and contribute to overall project strategy.
Lead interactions with clients and regulatory agencies on defined projects.
Build strong client relationships, manage client expectations and participate in client strategy discussions.
Support development of client budgets and business proposals.
Stay informed of relevant regulatory developments and contribute to regulatory/industry workshops, trainings and calls for collaboration .
Contribute to the ongoing improvement of internal regulatory processes and procedures.
Mentor and coach junior staff, line management if necessary.
Requirements:
Advanced degree (MSc/PhD) in a relevant field preferred.
Bachelor's degree in a life science field (e.g., biology, pharmacy, pharmacology, toxicology) or a related discipline necessary.
8-10+ years’ experience within regulatory sciences for development products preferred
Expertise with nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies for development products.
Experience of leading and delivering successful projects within budget and timeframe.
Experience managing client relationships within a consultancy setting preferred.
Demonstrated leadership and client-facing skills.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
-
Senior Manager Regulatory Sciences Expert
1 month ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeAt ProPharma Group, we are seeking a highly skilled Senior Manager Regulatory Sciences to lead our client projects and teams through all project phases. As a key member of our team, you will be responsible for independently leading discreet client projects, managing complex tasks, and contributing to overall project strategy.ResponsibilitiesProject...
-
Regulatory Sciences Director
3 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeAt ProPharma Group, we are seeking a highly skilled Senior Manager, Regulatory Sciences to join our team of experts in the field of regulatory sciences.Key Responsibilities:Lead discreet client projects, manage project teams, and ensure efficient project execution.Author global nonclinical/clinical aspects of regulatory documentation, including environmental...
-
Regulatory Sciences Manager
3 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full time{"Responsibilities": "Key ResponsibilitiesLead client projects through all phases, ensuring efficient project execution and contributing to larger projects.Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments and development plans.Project manage assigned projects in accordance with internal...
-
Regulatory Sciences Expert Leader
2 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeProPharma Group is a world-leading Research Consulting Organization (RCO) that empowers biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies.Job DescriptionWe are seeking an experienced Senior Manager, Regulatory Sciences to lead our client projects and teams through all project phases. As a...
-
Regulatory Sciences Expert
3 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeAt ProPharma Group, we are dedicated to empowering biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs. As the world's largest RCO (Research Consulting Organization), we partner with our clients through an advise-build-operate model across the entire product lifecycle.We offer a comprehensive suite of consulting...
-
Senior Regulatory Consultant
1 month ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeProPharma Group is seeking a Senior Regulatory Consultant to join its Regulatory Affairs Division. The successful candidate will work on projects from various Pharmaceutical companies, dealing with challenging and varied tasks that require result and client orientation, as well as excellent interpersonal skills.The role will involve working with Regulatory...
-
Regulatory Reporting Director
1 month ago
Stockholm, Stockholm, Sweden Nasdaq Full timeNasdaq is a leading financial institution dedicated to maintaining the highest standards of regulatory compliance and operational excellence. We are seeking a highly skilled and experienced Director of Regulatory Compliance to lead our team and ensure compliance with MiFIR, EMIR, and SFTR reporting requirements.The Director of Regulatory Compliance will...
-
Director of Regulatory Reporting
6 months ago
Stockholm, Sweden Nasdaq Full timeNasdaq is a leading financial institution dedicated to maintaining the highest standards of regulatory compliance and operational excellence. We are seeking a highly skilled and experienced Director of Regulatory Compliance to lead our team and ensure compliance with MiFIR, EMIR, and SFTR reporting requirements. Join us and play a crucial role in...
-
Director of Regulatory Compliance and Reporting
4 weeks ago
Stockholm, Stockholm, Sweden Nasdaq Full timeJob Description:Nasdaq is a leading financial institution dedicated to maintaining the highest standards of regulatory compliance and operational excellence. We are seeking a highly skilled and experienced Director of Regulatory Compliance to lead our team and ensure compliance with MiFIR, EMIR, and SFTR reporting requirements. Key...
-
Senior Consultant RS SAL
6 months ago
Stockholm, Sweden ProPharma Group Full timeFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
-
Stockholm, Sweden Visa Full timeJob DescriptionWhat's it all about?As Senior Data Science Manager, you are leading our growing Data Science function in the advisory service Visa Consulting & Analytics (VCA) and are part of Visa’s global Data Science community. You are accountable for driving the blueprint, development and delivery of data driven strategies and solutions for Visa’s...
-
Business Application Manager
3 months ago
Stockholm, Sweden Nordea Bank Full timeJob ID: 23159 We are now looking for a Business Application Manager (GFCP Senior Expert) to join KYC Application Management Team within Group Fiancial Crime Prevention. The successful candidate will support us in further development and maintenance of FinCrime applications as well as ensure their compliance with business objectives and regulatory...
-
Regulatory Risk Governance Expert
3 weeks ago
Stockholm, Stockholm, Sweden Nordea Bank Full timeAt Nordea Bank, we are seeking a seasoned Regulatory Risk Governance Expert to join our Compliance Risk Governance team. This role offers an exciting opportunity to leverage your expertise in regulatory analysis and risk management to drive compliance excellence.About the RoleWe are looking for a highly skilled professional with a strong background in...
-
Senior Process Manager
6 days ago
Stockholm, Sweden Sobi Full timeJob DescriptionManufacturing Science and Technology (MSAT) is part of the Global CMC, Science & Technology Department (GCSAT). GCSAT is responsible for optimization and life cycle management of Sobi's clinical and commercial manufacturing processes from internal and external network. MSAT ensures compliant, reliable, cost effective and sustainable...
-
Regulatory Compliance Specialist
6 months ago
Stockholm, Sweden CAE Full timeRole and Responsibilities CAE is a high-technology company, bringing the digital and physical worlds closer together to create a safer world. Our vision is to be the worldwide partner of choice in civil aviation, defence and security, by revolutionizing our customers’ training and critical operations with digitally immersive solutions to elevate...
-
Senior Governance Project Manager
2 weeks ago
Stockholm, Stockholm, Sweden Belmont Lavan Ltd Full timeJob Title: Senior Governance Project Manager - Contract ProfessionalAt Belmont Lavan Ltd, we are currently seeking an experienced Senior Governance Project Manager - Contract Professional to join our team. As a key member of our team, you will play a crucial role in delivering projects that meet the needs of our clients.About the Role:We are looking for a...
-
Senior Credit Risk Manager
1 month ago
Stockholm, Stockholm, Sweden 11196 Citibank Europe plc Sweden Full timeCredit Group Manager RoleWe are seeking a skilled Credit Group Manager to join our team at 11196 Citibank Europe plc Sweden. This is a unique opportunity to develop a business plan and credit program for the Commercial Banking Business.The successful candidate will be responsible for managing complex and critical professional disciplinary areas, leading and...
-
Regulatory Reporting Lead
2 weeks ago
Stockholm, Stockholm, Sweden Nasdaq Full timeNasdaq is a leading financial institution dedicated to upholding the highest standards of regulatory compliance and operational excellence. Our Regulatory Reporting team plays a crucial role in maintaining the integrity and quality of our reporting processes.Job DescriptionWe are seeking an experienced Director of Regulatory Reporting to lead our team and...
-
Stockholm, Sweden Danske Bank Full timeWould you like to combine Risk Management with Asset Management? This is an opportunity to do so and gain an extensive network across the Danske Bank Group. Senior/Chief Business Risk & Controls Officer to Asset Management Business Controls, Large Corporates & Institutions Business Controls & Product Management We are seeking a Senior/Chief Business...
-
Senior Product Manager, Pricing Optimization
2 weeks ago
Stockholm, Stockholm, Sweden Wolt Full timeWe are seeking a Senior Product Manager to lead our Consumer Pricing team. This role offers an exciting opportunity to build and shape a brand-new team from the ground up.Key Responsibilities:Oversight of centralized pricing tooling developmentBuilding experimentation framework for scalable testing and optimization of different pricing strategiesThis is a...