Senior Manager Regulatory Sciences Expert
3 weeks ago
At 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.
Responsibilities
- Project Management: Manage assigned projects in accordance with internal procedures, including approval of time entry and invoicing, budget monitoring, client liaison, and service growth.
- Regulatory Writing: Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments, development plans, briefing books, orphan designations, paediatric investigation plans, and marketing authorisation applications.
- Client Liaison: Lead interactions with clients and regulatory agencies on defined projects, build strong client relationships, manage client expectations, and participate in client strategy discussions.
- Team Leadership: Mentor and coach junior staff, provide expert guidance and technical expertise, and contribute to the ongoing improvement of internal regulatory processes and procedures.
Requirements
- Education: Advanced degree (MSc/PhD) in a relevant field preferred, or Bachelor's degree in a life science field (e.g., biology, pharmacy, pharmacology, toxicology) or a related discipline necessary.
- Experience: 8-10+ years' experience within regulatory sciences for development products preferred, with expertise in nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies for development products.
- Skills: Proven leadership and client-facing skills, with experience managing client relationships within a consultancy setting preferred.
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, and we provide a safe space where all employees feel empowered to succeed.
-
Regulatory Sciences Manager
2 months ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeSenior Manager, Regulatory SciencesProPharma Group is seeking a highly experienced Senior Manager, Regulatory Sciences to join our team. As a key member of our regulatory team, you will be responsible for leading client projects and project teams through all project phases, ensuring efficient project execution and contributing to larger...
-
Regulatory Sciences Expert
5 days 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...
-
Regulatory Sciences Manager
4 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeProPharma Group is a leading Research Consulting Organization (RCO) that partners with biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies. As a Senior Manager, Regulatory Sciences, you will lead client projects and project teams through all phases to ensure efficient project execution and...
-
Regulatory Sciences Director
1 week 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
4 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeAt ProPharma Group, we are seeking a highly skilled Regulatory Sciences Manager to join our team. This is a unique opportunity to leverage your expertise in regulatory sciences to drive the success of our clients.Key Responsibilities:Lead client projects through all phases, ensuring efficient project execution and contributing to larger projects.Author...
-
Regulatory Sciences Manager
3 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeProPharma Group is seeking a highly skilled Regulatory Sciences Manager to join our team. As a key member of our organization, you will be responsible for leading client projects and project teams through all project phases to ensure efficient project execution and contribute to larger projects.Key Responsibilities:Independently lead discreet client projects...
-
Regulatory Sciences Manager
2 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...
-
Senior Regulatory Affairs Specialist
4 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timeJoin Our Team as a Senior Regulatory ConsultantAt ProPharma Group, we are committed to delivering exceptional consulting services to the pharmaceutical industry. As a Senior Regulatory Consultant, you will play a critical role in helping our clients navigate the complex regulatory landscape in the Nordic region.About the RoleWe are seeking a highly...
-
Regulatory Risk Governance Expert
7 days 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 Legal Counsel
1 month ago
Stockholm, Stockholm, Sweden Trustly Full timeAbout TrustlyTrustly is a leading fintech company that is revolutionizing the way people pay online. Our mission is to make payments faster, easier, and more secure. We are a team of innovators, thinkers, and doers who are passionate about building a better way to pay.About the RoleWe are seeking a highly skilled Senior Legal Counsel - Regulatory to join our...
-
Senior Regulatory Advisor
4 weeks ago
Stockholm, Stockholm, Sweden rolfes.schierenbeckates Gmbh Full timeAbout the RoleWe are seeking a highly skilled Senior Consultant to join our team at Rolfes.Schierenbeck & Ates GmbH. As a Senior Consultant, you will play a key role in supporting our clients in the financial services sector with regulatory-driven business transformation and optimization.Key ResponsibilitiesMonitor regulatory developments and provide...
-
Senior Regulatory Advisor
1 month ago
Stockholm, Stockholm, Sweden rolfes.schierenbeckates Gmbh Full timeJob DescriptionAs a Senior Consultant at Rolfes.Schierenbeck&ates GmbH, you will play a key role in supporting our clients in navigating the complex regulatory landscape of the financial services sector.Key ResponsibilitiesMonitor regulatory developments and provide strategic advice to clients on compliance and risk management.Support clients in implementing...
-
Senior Regulatory Consultant
3 weeks 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...
-
Head of Regulatory Affairs
1 month ago
Stockholm, Stockholm, Sweden Merz Therapeutics - Europe Full timeHead of Regulatory Affairs / QA/ Product Safety (m/f/d) NordicsWe are seeking an exceptional individual to take on the role of Head of Regulatory Affairs / QA/ Product Safety for the Nordic region. In this pivotal position, you will report directly to the Nordic General Manager and be an integral member of the Merz Therapeutics Nordic Leadership team. Your...
-
CMC Regulatory Affairs Specialist
1 month ago
Stockholm, Stockholm, Sweden QRIOS Full timeAbout the RoleWe are seeking a highly skilled CMC Regulatory Affairs Associate to join our team at QRIOS Life Science. As a key member of our CMC Regulatory Business Development Team, you will be responsible for providing support to Chemistry, Manufacturing and Control (CMC) regulatory contributions required for the management of Product Divestments to 3rd...
-
Head of Regulatory Affairs and Quality Assurance
4 weeks ago
Stockholm, Stockholm, Sweden Merz Therapeutics - Europe Full timeRegulatory Affairs and Quality Assurance ExpertWe are seeking an experienced Regulatory Affairs and Quality Assurance professional to join our team at Merz Therapeutics Nordics AB. As a key member of our Nordic Leadership team, you will play a crucial role in shaping our regulatory strategies, ensuring pharmacovigilance, and upholding quality standards...
-
Tax Compliance Regulatory Counsel
1 month ago
Stockholm, Stockholm, Sweden Sovos Compliance Full timeAbout Sovos ComplianceSovos Compliance is a global leader in tax, compliance, and trust solutions. Our purpose-built software platform provides an unparalleled level of integration with business applications and government compliance processes.Job Title: Regulatory Liaison Counsel - ISVs and Embedded PartnersWe are seeking a highly skilled Regulatory Liaison...
-
Senior Grid Development Manager
4 weeks ago
Stockholm, Stockholm, Sweden ib vogt Full timeCompany Overviewib vogt is a leading global developer of renewable energy projects, with a strong focus on photovoltaics and battery storage. Our mission is to advance the transition to a sustainable energy future, and we're seeking a talented individual to join our team as a Senior Grid Development Manager.Job SummaryWe're looking for a proactive and...
-
Senior Risk Expert, Model Risk Regulation Lead
1 month ago
Stockholm, Stockholm, Sweden Nordea Bank Full timeJob Opportunity:We are seeking a Senior Risk Expert, Model Risk Regulation to lead our Model Risk team's role in interpreting and applying regulations related to models used in Nordea. The successful candidate will be responsible for managing engagement with regulators on model risk matters on behalf of the Model Risk team.About the Role:The Senior Risk...
-
Director of Regulatory Compliance
1 month ago
Stockholm, Stockholm, Sweden Nasdaq Full timeDirector of Regulatory ReportingNasdaq 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...