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

Total Quality Logistics

Entry Level Sales Representative Job at Total Quality Logistics

...negotiation skills to secure deals for freight transportation while managing customer shipments from pickup to delivery. No prior experience is necessary; our best in-class paid freight broker training and mentorship program will teach you everything you need to know...

Ltblender

Marketing / Social Media Manager Job at Ltblender

...DescriptionThis is a full-time hybrid role for a Marketing/Social Media Manager based in the Portland, Oregon. The role involves... ...engaging copy, and managing and coordinating work with freelancers. Some work from home options are available for this position.Who we are...

ZRG Partners, LLC

Physics & Engineering Teacher Job at ZRG Partners, LLC

...commitment to personal growth and values. Position Summary We are seeking a passionate and experienced part-time Physics & Engineering Teacher to join our faculty for the 20252026 school year. The ideal candidate will teach one period per day, four days a week...

Taurus Industrial Group, LLC

Painter Job at Taurus Industrial Group, LLC

...seeking a skilled and detail-oriented Industrial Painter to join our dynamic team. The ideal candidate will have a strong background in painting and finishing industrial components, utilizing various techniques and tools to ensure high-quality results. This role requires...

Randstad USA

Structural Steel Welder/Fitter Job at Randstad USA

...Job Description Job Description Are you a skilled Structural Steel Fitter looking for a dynamic weld shop environment? We're searching... ...throughout the shop. Collaborate effectively with welders, project managers, and potentially mentor junior fitters. Uphold...

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

T0lVQmVGbm8xWDdtV2FBdlJVL0ZDWDFFZ2c9PQ==