Regulatory Affairs Associate CMC
We are currently searching for a skilled professional to join a well-known client’s team as a Regulatory Affairs Associate, CMC in Framingham, Massachusetts. The Regulatory Affairs Associate, CMC position independently provides project team representation while working closely with Manufacturing, Quality, Technical Support and service groups and Site Senior management to compile the required information in accordance with established timelines Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Monitors and tracks information, assuring accurate communication of the current status of post-approval change control assessments and submissions
- 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 and submissions
- Provides direction in managing information to and from other departments
- Reviews technical documentation (Project Plans, Change Control, Deviations, CAPA, Batch Records)
- Recommends and 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
- Ensure products manufactured and tested adhere to the regulatory licenses
- Provide regulatory guidance and strategy for site projects
- Responsible for drafting and finalizing CMC submission with Biosurgery RA-CMC product lead
- A minimum of 10 years of experience in regulatory, manufacturing, technical development or QA/QC
- Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to biologics and medical device regulations
- Strong understanding of manufacturing processes
- Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, 30 Day Notifications, 180 Day Supplements, master file updates) for medical device
- Proficient in MS Word, Excel, PowerPoint, MS Project, and TrackWise
- BS, MS or PhD in Biology, Chemistry, Engineering or related field.
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.