Job Description

Responsibilities:
The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions.
This is a meaningful individual contributor who will partner with key business, functional and business partners to ensure commercial objectives are achieved.
Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products.
Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership.
Make decisions regarding patient safety signals, indications, risk and other sophisticated change or regulated content creation/modification triggers.
Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving implementation of complex global and local labeling and other regulated solutions in accordance with the end-to-end regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals.
Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on the market, including monitoring, evaluating, and internally communicating new and existing applicable regulatory requirements.
Lead or support global technology, process, and solution initiatives to standardize, and enable standard process in labeling and content management, including requirements, use cases and translations.
Deliver responses, solutions, and find opportunities to improve based upon quality initiatives, including audits and risk mitigation.
Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions.
Requirements:
Bachelor's degree in pharmacy, biochemistry or similar science related field preferred.
Minimum 5 years of pharmaceutical regulatory or regulated content management (e.g., labeling, or Company Core Data Sheets) experience.
Ability to run sophisticated projects and timelines in a matrix team environment.
Strong project management and organizational skills.
Ability to independently identify compliance risks and raise when necessary.
#J-18808-Ljbffr

Job Tags

Full time, Local area,

Similar Jobs

South Moon Under

Summer Marketing Intern Job at South Moon Under

...stores,weaimtoconnectandspreadthelove. Overview TheMarketingInternwillsupportthemarketingteamintheareasofdigital,... ...WorkingknowledgeofMicrosoftBusinessSuite Timing Summer2025 TuesdayThursdaystartingMid-MayMid-Aug(canbe...

Lyons Logistics

No CDL Delivery Driver--Amazon Packages--Sterling, VA Job Job at Lyons Logistics

No CDL Delivery Driver--Amazon Packages--Sterling, VA JobDelivery DriversLyons Logistics... ...orders, large or small, are delivered on time at the right place.General Responsibilities... ...21 years of age or olderJob Types: Full-time, Part-timeSalary: $16.25 /hourPay...

palo_alto_networks

Security Solutions ArchitectEndpoint IOT ICSSCADA Job at palo_alto_networks

PALO ALTO NETWORKS is the fastest growing security company in history. We offer the chance to be part of an important mission: ending breaches... ...communications and functionality (e.g., Office 365, Exchange, SAP, Oracle)Experience with cloud applications and environments, e....

Allara Health

Social Media & Community Manager Job at Allara Health

...women with hormonal health needs. About the Role We're looking for a strategic, creative, and self-motivated Social Media & Community Manager to lead Allara's presence across organic social, influencer partnerships, and content-driven performance campaigns. You'll own...

Porcelanosa USA

Administrative Sales Support Job at Porcelanosa USA

...Job Description Job Description Job Title: Administrative Sales Support Reports To: Sales Manager Benefits: ~100%... ...administration, or similar. Experience with sales industry software like Salesforce and client relationship management (CRM) systems...

Regulatory Affairs Manager (Boston) Job at Katalyst HealthCares and Life Sciences, Boston, MA

Y1NDa2hiOHFITlFlQXdYekQ2WVB6a2JmdVE9PQ==