vor 2 Tagen

Regulatory Affairs CMC Manager (m/f)

Bayer Consumer Care AG

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Regulatory Affairs CMC Manager (m/f)

The Regulatory Affairs CMC Manager is assigned CMC tasks of new and existing products. For each product, he/she is responsible for:

Responsibility for the CMC change management for assigned NPDs
and marketed products, which includes tracking of CMC changes and
processing of requests for related documentation (evaluation,
consolidation, prioritization and review), responsibility for coordination
of responses to health authority questions, and for implementation of
CMC changes after HA approvals with product supply, to ensure
regulatory CMC compliance in close cooperation with the relevant
global Dossier owners, regional, and country RA functions, CMCD
team, Product Supply, to ensure early identification of major regulatory
hurdles and issues with regard to CMC related topics, and
coordination of respective corrective actions.
Responsibility for the regulatory support to the RA Strategy team with
regard to CMC tasks which includes support to new registrations and
CMC related topics for assigned products in close cooperation with
Dossier owners in Strategy and relevant stakeholders.
Ensures adequate surveillance of the CMC- related regulatory
environment for assigned products and anticipates and influences
changes in this environment globally.
Responsibility for timely availability and final content of CMC for
assigned products to Health Authorities, including responses to health
authority questions.
May act as mentor for Dossier owners, newcomers within the RA LCM
and Strategy organization and seeks close alignment of CMC activities
across the Regulatory Affairs.
Proposes and implements standards concerning CMC documentation
in close co-operation with CMCD, Dossier Owners, global/regional and
local RA functions, and Product Supply.
Responsibility for achieving assigned global regulatory affairs CMC
project objectives.
Represents RA in CMC development teams if required
To ensure globally harmonized regulatory CMC compliance for
assigned Bayer CH Products
Proposes and implements standards concerning CMC documentation
in close co-operation with global, regional, and local RA functions, and
BHC Product Supply.
Ensures adequate surveillance of the CMC-related regulatory
environment for assigned products and anticipates and influences
changes in this environment globally.
Develops of appropriate CMC regulatory strategies for maintenance of
assigned projects by designing and assessing regulatory strategy
options on a global basis, for routine business and special projects as
needed.
Ensuring that CMC activities, plans, strategies, and outcomes are
aligned with Product Supply Consumer Care, and/or CMCD and RA
Strategy team as appropriate
Manages the preparation of CMC registration dossiers related to
assigned products and proactively identifies and tracks regulatory
activities and /or issues and risks and brings these to the attention of
RA CH management as necessary
Provides CMC information, documentation or policy support to local
regulatory affiliates to enable fulfillment of health authority
requirements throughout the product lifecycle
Implement appropriate Bayer Consumer Health and RA business
policies, processes and standard operating procedures
Regularly reports status measures to the RA LCM Head, and
appropriate stakeholders