Aktuelle Jobs im Zusammenhang mit Regulatory CMC Lead - Baar, Zug - Biogen Idec
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Senior Manager, Regulatory CMC Lead
vor 4 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout the RoleWe are seeking a highly skilled Senior Manager, Regulatory CMC Lead to join our team at Biogen. In this role, you will be responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products.Key...
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Senior Manager, Regulatory CMC Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout the RoleIn this pivotal position, you will provide expert Regulatory CMC guidance to shape the global regulatory strategy, operations, and planning for assigned projects/products. Your responsibilities will include preparing and compiling submission/documentation for small molecule projects, collaborating with the Regulatory CMC Lead and key...
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Regulatory CMC Small Molecules Team Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout this roleThe Regulatory CMC Small Molecules Team Lead will be responsible for leading a team of regulatory professionals in the development and implementation of global CMC regulatory strategies for small molecule products. This role will require strong leadership and communication skills, as well as the ability to work effectively in a matrixed...
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Senior Manager, Regulatory CMC Small Molecule Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout the RoleIn this position, you will provide Regulatory CMC expertise to support the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products. Your responsibilities will include preparation and compilation of submission/documentation for specific small molecule projects,...
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Regulatory CMC Small Molecules Team Lead
vor 1 Monat
Baar, Zug, Schweiz Biogen VollzeitAbout this roleJoin Biogen's Regulatory CMC TeamAs a key member of our Regulatory CMC team, you will be responsible for leading the small molecule portfolio and ensuring the timely approvals of clinical trial applications, initial marketing authorization applications, and lifecycle changes.Key ResponsibilitiesLead the development of working processes and...
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Commercial CMC Asset Lead
vor 2 Monaten
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Commercial CMC Asset Lead
vor 4 Wochen
Baar, Zug, Schweiz Biogen VollzeitAbout This RoleWe are seeking a seasoned leader to join our Asset Development and Portfolio Management (ADPM) team as a Commercial CMC Asset Lead. This role is responsible for leading a commercial asset and all life cycle management activities, including asset strategy, development, supply, and life cycle management planning.Key ResponsibilitiesDevelop and...
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Commercial CMC Asset Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen VollzeitAbout This RoleBiogen is seeking a seasoned leader to join our Asset Development & Portfolio Management (ADPM) team as a Commercial CMC Asset Lead. This role is responsible for leading a commercial asset and all life cycle management activities, including asset strategy, development, supply, and life cycle management planning.Key ResponsibilitiesDevelop and...
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Commercial CMC Asset Lead
vor 4 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout This RoleThe Pharmaceutical Operations and Technology (PO&T) Division is seeking a seasoned leader to fill the Commercial CMC Asset Lead position. This role is a key member of the Asset Development & Portfolio Management (ADPM) team, providing cross-functional leadership across PO&T's line functions for an asset.Key ResponsibilitiesDevelop and deliver...
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Commercial CMC Asset Lead
vor 4 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout This RoleThe Pharmaceutical Operations and Technology (PO&T) Division is seeking a seasoned leader to fill the Commercial Asset Lead position. As a key member of the Asset Development & Portfolio Management (ADPM) team, this individual will provide cross-functional leadership across PO&T's line functions for an asset.Key ResponsibilitiesDevelop and...
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Commercial CMC Asset Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout This RoleThe Pharmaceutical Operations and Technology (PO&T) Division is seeking a seasoned leader to fill the Commercial Asset Lead position. As a key member of the Asset Development & Portfolio Management (ADPM) team, this individual will provide cross-functional leadership across PO&T's line functions for an asset.Key ResponsibilitiesDevelop and...
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Regulatory Compliance Specialist
vor 1 Monat
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Software Development Team Lead
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Software Development Team Lead
vor 1 Monat
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Software Development Team Lead
vor 3 Wochen
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Software Development Team Lead
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Software Development Team Lead
vor 2 Monaten
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Software Development Team Lead
vor 2 Wochen
Baar, Zug, Schweiz Medela VollzeitAs a seasoned leader, you will spearhead the transformation of our Software team into a cutting-edge unit specializing in design and development of contemporary medical devices solutions in vacuum technology applications. You will apply SAFe / Agile methodologies, drive solution-level thinking, and system architecture, and stay updated on emerging...
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Software Development Team Lead
vor 2 Wochen
Baar, Zug, Schweiz Medela VollzeitMedela is seeking a highly skilled Software Development Team Lead to join our team. As a key member of our organization, you will be responsible for leading the transformation of our Software team into a cutting-edge unit specializing in design to develop contemporary medical devices solutions in vacuum technology applications.Key Responsibilities:Lead and...
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Software Development Team Lead
Vor 7 Tagen
Baar, Zug, Schweiz Medela VollzeitTransformative Leadership in Software DevelopmentAs a Team Lead for Software Development at Medela, you will spearhead the transformation of our software team into a cutting-edge unit specializing in design and development of contemporary medical devices solutions in vacuum technology applications. Your leadership will drive solution-level thinking, system...
Regulatory CMC Lead
vor 2 Monaten
In this position, you will provide Regulatory CMC expertise to support the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products. Your responsibilities will include preparation and compilation of submission/documentation for specific small molecule projects, working closely with the Regulatory CMC Lead and key stakeholders. You will also serve as the primary contact for affiliates on Regulatory CMC activities in the assigned regions and manage routine and non-routine Health Authority interactions as delegated.
Key Responsibilities- Provide strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and work flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
- Prepare and deliver CMC Regulatory operational plans for products in the assigned regions and support the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs).
- Responsible for submission from defining content to leading reviews as required to ensure complete, concise, and accurate submissions to Health Authorities.
- Write and/or review regional and global CMC submission documents and responses to Health Authority questions.
- Monitor changes in the Regulatory CMC environment to support and advise key stakeholders and teams.
- Provide input into Regulatory CMC risks assessment and mitigation plans and ensure they remain in line with the overall global Regulatory CMC strategy.
- Coordinate and complete regulatory assessments of CMC changes in the designated systems.
- Responsible for assuming responsibilities from the Team Lead or Global Regulatory CMC lead, as agreed and delegated, and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions.
- Responsible for leading or assisting in delivery of project assignments supporting business needs, e.g., representation of Regulatory CMC on cross-functional work streams.
- Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC standards and SOPs, as assigned.
- Ensure that appropriate records are maintained in the designated system for submission in assigned regions.
- BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
- Minimum 3 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
- Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities).
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products.
- Experience of direct communication and negotiation with regulatory agencies on CMC matters.
- Knowledge of GMP requirements and standard systems (e.g., change management systems).
- Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure.
- Leadership/Management Skills: Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.
- Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy.
- Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
- Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
- Demonstrated competency in operations, planning, project management, and tracking projects of high complexity and risk with clearly defined critical paths.
- Proven ability to manage projects across global locations/time zones.
- Proven ability to create strong, productive working relationships in a global setting with many different cultures.
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.
Caring Deeply. Achieving Excellence. Changing Lives.
