Job Details
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Regulatory Consultant/CMC, Cell/Gene Therapy
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Posted Jan 19, 2024
At Pharmatech, we bring together the finest minds in life sciences to create innovative strategies for essential and next-generation medicines and diagnostic tests for the global market. We are an established consultancy that serves the complex needs of pharmaceutical manufacturers and regulated life science companies as they bring innovative new therapies to the market. In 2021, we became the consulting arm of USP s (US Pharmacopeia) Global health group, and we share a common goal of helping manufacturers bring safe, quality medicines and treatments to patients who need them.In support of our mission, we are seeking Regulatory Consultants to support our clients projects.
About The Job
This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) and clinical aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with stakeholders (e.g., other RA functions, Pharmaceutical Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (e.g., CMC strategy/planning for NMEs), driving global CMC RA related activities and successfully executing regulatory strategies in collaboration with stakeholders.
Job Responsibilities
Acts as a CMC and clinical SME for SMALL MOLECULE drug development and regulatory elements of the drug development process
Acts as regulatory expert by global project teams/task forces and is accountable for recommending global regulatory strategy.
Works closely with other individuals/groups within Pharmatech Associates to ensure consistency and to identify options for risk discussions.
Requires expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure compliance within the organization.
Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements.
In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities.
Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.
Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders.
Oversees global submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs.
Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs.
Provides regulatory guidance for compendial issues, JP/EP/USP and other national compendial monographs, and monograph preparation.
Qualifications
B.S. in Chemistry or equivalent degree plus 10 years industry experience directly in Regulatory Affairs or in CMC and clinical regulatory or role withregulatory submission responsibilities.
Experience with global regulatory aspects of CMC and clinical for cell and gene therapy drug products across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
Advanced interpersonal written and oral communication skills, as well as advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment
Ability to manage complex projects by exercising independent decision making and analytical thinking skills
Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance
Demonstrated track record for successful Health Authority interactions related to regulatory submissions.
Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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