Job title:
CMC Project Manager
Company:
Perrigo
Job description
Description OverviewPerrigo are bringing an exciting new proposition to the Warsaw market and we would love to hear from experienced CMC regulatory affairs Project managers.Help us lay the foundations of our new Business Services Centre based in Mokotów. We need a diverse group of action-oriented colleagues who have the desire to go beyond the transactional elements of their role and be part of building something truly special!
- Join a collaborative, international environment with many cross-functional interactions and opportunities. Build your career in a Global organisation with opportunities for career growth and supported learning.
- Thrive from a trust-based leadership approach that encourages innovation and transparent communication.
- Access extensive training and development platforms, including our internal GROWyou program, to support continuous learning, skill development, and professional advancement.
- See your talents recognised and rewarded through extended responsibilities and varied career move opportunities
***We currently offer a hybrid working pattern with 3 days in the office and 2 days working remotely.Scope of the Role
- Lead CMC Regulatory Affairs Projects; providing updates to business and reporting against project plans
- Develop regulatory strategies for CMC (chemistry Manufacturing & control) aspects of new MAAs( including Responses to HA questions), New Product Development projects, and life cycle maintenance activities
- Complete due diligence on time for any assigned product dossiers, identifying risks and opportunities
- Identify risks and opportunities for assigned projects
- Support the technical team and provide any scientific expertise to define the development or validation plan for assigned projects
- Review technical documentation generated by the site during the development project or validation of the site transfer in particular protocols and development reports, validation of processes and analytical methods, test methods and specifications and stability protocol and reports
- Support Change Controls – providing RA assessment, strategy and appropriate actions
- Manage, coordinate, write and maintain technical part/quality ( CMC ) part of CMC dossiers (e.g complex MA Variations such as Site Transfer and Reformulation projects)
- Responsibility of CMC submission to ensure continuity of supply and new products meet submission timeline
- Support project team to resolve regulatory issues with Health Authorities
- Support resolution and action related to artwork related issues
- CMC support for MDR related changes to the medicinal CTD
- CMC expertise and RA activity in support of emerging ingredient issues in compliance with related guidance
- Play an active role in quality management of product by providing expertise in managing request for changes , preparing annual product quality review and any matters related to product quality control
- Develop, roll out and maintain relevant internal procedures and best practices
- Maintain the integrity of regulatory data in the relevant databases
- Interpret and implement legislation, follow changes in national regulations and legislations and proactively manage impact of these changes
Experience RequiredMinimum Qualification
- University Degree or equivalent scientific qualification
- Minimum of 7 years of relevant work experience (preferably in CMC Regulatory Affairs or R&D), with a practical experience of working with at least one of the specific product types, a background knowledge of healthcare products (e.g. medicines, medical devices, cosmetics)
Minimum Work Experience
- Must have strong experience in CMC and pharmaceutical life cycle management.
- Must have experience in due diligence of the CMC dossiers ( 3.2.P and 3.2.S)
- Desirable to have experience in project management
- Desirable to have experience in Nitrosamines project management
Person Profile
- Self-motivated, flexible and open to changing requirements
- Ability to work effectively, both autonomously and in teams
- Good interaction skills with internal and external stakeholders.
- Ability to handle multiple complex projects in parallel, with high accuracy and attention to detail
- Highly driven with enthusiasm to meet requirements and cope under demanding pressure
- Profound organizational and problem-solving skills
- Solid communicator in English. Additional language (e.g. French) skills are desirable
- Passion for healthcare products and the underlying technical and regulatory compliance aspect
- Developing leadership skills with evidence in effective negotiation, strategic thinking and prioritisation
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Expected salary
Location
Warszawa, mazowieckie
Job date
Wed, 21 Aug 2024 22:34:41 GMT
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