Aktuelle Jobs im Zusammenhang mit Director, Regional Regulatory Strategist - Basel - Moderna Therapeutics
-
Director, Regional Regulatory Strategy, Infectious
vor 3 Monaten
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: The Director, Regional Regulatory Strategist - ID will have the opportunity to lead the regulatory strategy with the European Medicines Agency (EMA), act as the regulatory strategy partner for International countries, and provide regulatory support to the VP, Regulatory Affairs - International. This is a new role intended for a forward-looking,...
-
Director, Regional Regulatory Strategy, Infectious
vor 4 Monaten
Basel, Schweiz Moderna Vollzeit**The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...
-
Director, Regulatory Affairs, Regional Regulatory
vor 3 Monaten
Basel, Schweiz Moderna Vollzeit**The Role**: **Here's What You’ll Do**: Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, MAA etc.) Work with the International local regulatory leads in Canada, Asia,...
-
Director Regulatory Affairs
vor 3 Monaten
Basel, Schweiz BeiGene VollzeitGeneral Description: The Director Regulatory Affairs will be responsible for developing and implementing regulatory strategies for the designated program to secure and maintain marketing authorization in line with business objectives, and in coordination with key internal stakeholders. Essential Functions of the job: - Act as the representative of European...
-
Associate Director Regulatory Affairs Biosimilars
vor 3 Monaten
Basel, Schweiz Abbott Laboratories Vollzeit**Abbott **is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160...
-
Associate Director, Regulatory Affairs
vor 4 Monaten
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: Leads and continues to build the Clinical Trial Application (CTA) regulatory group, responsible for providing effective operational and regulatory support for assigned regulatory clinical trial submissions and maintenance activities, including preparation and submission of regulatory dossiers, and maintenance of regulatory databases and...
-
Sr. Director of Regulatory Compliance
vor 3 Monaten
Basel, Schweiz Moderna Vollzeit**The Role**: The Sr. Director of Regulatory Process and Compliance position will work cross-functionally to drive activities that will ensure a state of continuous compliance at Moderna and build inspection-preparedness capabilities and sustain a positive compliance reputation between Moderna’s business partners, Health Authorities and cross-functionally...
-
Director, Global Regulatory Affairs
vor 3 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...
-
Director, Global Regulatory Affairs
vor 3 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...
-
Director, Regulatory Science
vor 3 Monaten
Basel, Schweiz Moderna Vollzeit**The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...
-
Basel, Schweiz Swiss Biotech Association VollzeitDirector regulatory affairs, small molecule strategy Location: Basel, Switzerland **Responsibilities**: The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals. Lead and manage FDA and Health Authority interactions with FDA and...
-
Director - Global Regulatory Lead
Vor 3 Tagen
Basel, Schweiz VECTURA FERTIN PHARMA VollzeitContract Type: Permanent Closing date: Reference: VN1863 - About us Who we are Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery...
-
Regulatory Affairs Associate Director, Digestive
vor 3 Monaten
Basel, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Director Regulatory Toxicology
vor 3 Monaten
Basel, Schweiz Vectura VollzeitAbout the role: As the Director Regulatory Toxicology, you and your team will work closely with the Scientific Innovation leadership and play a pivotal role in the development and success of our Innovation Centre in this dynamic and quickly evolving market. - This is a real opportunity to play a central role in ensuring the continuation and ongoing...
-
Associate Director, Regulatory Affairs
vor 4 Monaten
Basel, Schweiz VECTURA FERTIN PHARMA VollzeitContract Type: Permanent Closing date: Reference: VN1710 - Who we are - Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. -...
-
Regulatory Affairs Director for Small Molecules
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Lonza VollzeitRegulatory Affairs Expert for Small MoleculesLonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to devise innovative solutions that help businesses improve lives. In return, we empower our people to own their careers, driving meaningful impact through their ideas.We are...
-
Senior Clinical Pharmacology Strategist
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitJob Title: Senior Clinical Pharmacology StrategistAt Ridgeline Discovery GmbH, we are seeking a highly skilled Senior Clinical Pharmacology Strategist to join our team. As a key member of our clinical development team, you will play a pivotal role in advancing our pipeline of innovative therapies for obesity and cardiometabolic...
-
Senior Clinical Pharmacology Strategist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitAbout Ridgeline Discovery GmbHRidgeline Discovery GmbH is a biotechnology enterprise focused on advancing innovative therapies for the treatment of obesity and cardiometabolic conditions.Job Title: Senior Clinical Pharmacology StrategistWe are seeking a highly motivated and experienced Senior Clinical Pharmacology Strategist to join our team. As a key member...
-
Regulatory Affairs Director
vor 1 Woche
Basel, Basel-Stadt, Schweiz headcount AG VollzeitJob DescriptionJob Title: Senior Regulatory Affairs ManagerCompany: headcount AGLocation: Basel (hybrid)Duration: 6 monthsWorkload: Full-timeAbout the Role:We are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at headcount AG. As a key member of our regulatory affairs team, you will be responsible for providing operational...
-
Associate Director Regulatory Affairs Small
vor 3 Monaten
Basel, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
Director, Regional Regulatory Strategist
vor 3 Monaten
**The Role**:
The Director, Regional Regulatory Strategist - ID will have the opportunity to lead the regulatory strategy with the European Medicines Agency (EMA), act as the regulatory strategy partner for International countries, and provide regulatory support to the VP, Regulatory Affairs
- International. This is a new role intended for a forward-looking, creative, and agile regulatory Director able to anticipate and address the challenges involved in supporting the interactions with the EMA and other International agencies for messenger RNA therapeutics as a new drug modality.
**Here's What You’ll Do**:
Act as the EMA primary contact point for the assigned program
Develop and contribute to content and format for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, DSURs, MAA etc.
Work with VP-RA International and Global Regulatory Teams regarding the development and execution of regulatory strategy in the EU and International countries
Coordinate aspects of regulatory submissions relevant to assigned projects or programs
Identify and assess regulatory risks for assigned projects or programs
Contact relevant regulatory agencies relevant to assigned projects or programs, as appropriate
Prepare and deliver effective communications and presentations for external and internal audiences
**Here’s What You’ll Bring to the Table**:
Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
10+ years of experience in the pharmaceutical industry. 7+ years of experience in Regulatory strategy
Strong knowledge of current EU and International regulations related to the clinical, and nonclinical development
Strong experience with CTD format and content regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Ability to work both independently and within or leading project teams, committees, etc. to achieve business goals and objectives in a fast-paced environment
Ability to effectively collaborate effectively in a dynamic, cross-functional, matrixed environment to drive meeting each program’s critical regulatory milestones
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Fluency in English is required. The knowledge of other European languages is a plus.
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
LI-TR1
