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Regulatory Affairs Specialist V Regulatory Affairs Specialist V
Ref No.: 17-15744
Location: Allston, Massachusetts
Reporting to the Associate Director, Global Regulatory CMC, this position will provide Regulatory CMC support for the Allston Biologics site.
Independently provides project team representation while working closely with Manufacturing, Quality, Technical Support/service groups and Site Senior management to compile the required information in accordance with established timelines;
Monitors and tracks information, assuring accurate communication of the current status of post-approval change control assessments and submissions.
Interacts with RA colleagues world-wide;
Coordinates and prepares regulatory document packages to support post-market changes at the Site;
Provides project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions. Provides direction in managing information from/to other departments.
Reviews technical documentation (Project Plans, Change Control, Deviations, CAPA, Batch Records);
Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals; Responsible for determining if changes and deviations are in compliance with regulatory licenses (in all applicable countries) for the commercial products manufactured at the Allston Landing Facility.
Ensure products manufactured and tested at Allston Landing Facility adhere to the regulatory licenses.
Provide regulatory guidance and strategy for site projects.
Responsible for drafting and finalizing CMC submission with Cerezyme RA-CMC product lead.
Knowledge of Cerezyme regulatory history (including Consent Decree) and Allston Landing ways of working

BS, MS or PhD in Biology, Chemistry, Engineering or related field.
Excellent written and verbal communication skills.
Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
Strong understanding of manufacturing processes
Excellent organizational skills, demonstrated ability to prioritize multiple projects.
Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels. Excellent communication skills and ability to influence across the broadest of constituencies.
Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, Client, Variations) for biologic and/or drug productsAbility to effectively interpret guidance and provide recommendation to key stakeholders.
Regulatory, Manufacturing, QA/QC experience
Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
Ability to set ambitious and realistic targets, drive for results and build accountability.
Ability to effectively manage the balance between delegation/empowerment and a hands-on approach