Regulatory CMC Strategist

Icon Plc•Blue Bell, PA

76d

About The Position

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 currently seeking a Manager, Regulatory Strategy with regulatory CMC expertise to join our diverse and dynamic team. As a Manager, Regulatory Strategy at ICON, you will play a pivotal role in shaping and implementing strategic regulatory plans to the development and approval of innovative treatments and therapies. Your expertise will be crucial in navigating complex regulatory landscapes and ensuring compliance with global regulatory requirements. The role will work with a client focusing on: The Strategist, Global Regulatory Affairs CMC is responsible and accountable for: Defining, coordinating and implementing global CMC regulatory strategies for product- specific development and life-cycle activities Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets. The role liaises directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters. Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval. Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives. Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals Facilitates the communication and flow of regulatory information (regulatory frame work, scope and project timelines) to all relevant stakeholders. Identifies and recommends the most effective CMC regulatory strategies to assure a first pass regulatory approval of initial application and lifecycle supplements/variations Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant stakeholders or functions in line with client's operating model with the purpose to obtain, maintain and extend BU product registrations in global markets. Provides proactive guidance and regulatory strategies to support PDT product teams Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs. In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams. In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully documented in the respective quality management system. Provides tactical and strategic regulatory input and guidance, including active partici- pation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards reates high quality, compliant regulatory CMC documents within defined timelines as per BU objectives Participates in discussions and negotiations with regulatory authorities, agents, business partners, proactively and as required Assists in the conduct of regulatory agency inspections and compliance audits.

Requirements

Bachelor's or advanced degree in a relevant scientific or regulatory discipline.
Proven experience in regulatory strategy within the pharmaceutical or CRO industry (5-8 years).
In-depth knowledge of global regulatory requirements for drug development and submissions.
Strong analytical and strategic thinking skills, with the ability to navigate complex regulatory scenarios.
Excellent communication skills, fostering partnership across diverse teams.

Responsibilities

Defining, coordinating and implementing global CMC regulatory strategies for product- specific development and life-cycle activities
Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets.
The role liaises directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters.
Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval.
Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives.
Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals
Facilitates the communication and flow of regulatory information (regulatory frame work, scope and project timelines) to all relevant stakeholders.
Identifies and recommends the most effective CMC regulatory strategies to assure a first pass regulatory approval of initial application and lifecycle supplements/variations
Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant stakeholders or functions in line with client's operating model with the purpose to obtain, maintain and extend BU product registrations in global markets. Provides proactive guidance and regulatory strategies to support PDT product teams
Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs.
In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams.
In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully documented in the respective quality management system.
Provides tactical and strategic regulatory input and guidance, including active partici- pation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations
Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards
Creates high quality, compliant regulatory CMC documents within defined timelines as per BU objectives
Participates in discussions and negotiations with regulatory authorities, agents, business partners, proactively and as required
Assists in the conduct of regulatory agency inspections and compliance audits.

Benefits

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.

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