Regulatory Affairs CMC Author
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are seeking a highly motivated and qualified regulatory CMC author/writer for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.
The Author works in a highly matrixed, global product team-oriented environment and will closely collaborate within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant Takeda R&D functions to provide consistent and aligned regulatory CMC submission approaches globally, regionally and locally.
The Author is responsible and accountable for:
- Manages routine CMC authoring and submission activities for an assigned product or product portfolio to assure the preparation of high quality and compliant global regulatory submission.
- Maintains regulatory CMC dossier templates in alignment with current ICH and relevant regional regulatory requirements and standards
- Maintains a core source file management system to support all global plasma CMC submission activities
- Keeps current on global submission requirements, standards and formats.
- Assures an effective collaboration with Global Regulatory Affairs CMC Strategists, Global Manufacturing and Global Quality SMEs for the timely preparation and review of regulatory submission documentation.
- Acts as liaison with relevant regulatory operations teams (e.g, Publishing)
- Supports the development of efficient submission authoring and preparation procedures to assure timely completion of submission packages per business and regulatory timelines
- Helps maintain relevant submission-related systems and trackers and assures that global CMC regulatory submission documentation is consistent in terms of content and aligns with the global dossier templates.
- Identifies country-specific submission requirements.
- Collaborates with Global Regulatory CMC Strategists to define detailed scope of submissions.
- Coordinates document review sessions to collate comments and corrections of drafted documents and prepares the documents for final approval for timely submission.
Your profile
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 3 - 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of global regulatory requirements and guidelines for clinical trials / product registration and life-cycle activities.
- Proven ability to manage regulatory submissions and interactions with regulatory agencies.
- Excellent communication, attention to detail, and problem-solving skills.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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