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

Local area,

Similar Jobs

All Weather Seal of West Michigan Inc

Sales Representative Job at All Weather Seal of West Michigan Inc

...Job Description Job Description Description: Sales Executive In-Home Solutions | $100K+ First-Year Potential | No Cold Calling... ...your pitch and close more deals ~ W2 employment with health, dental & vision after 90 days ~ Real career path potential to move...

One Hour Heating and Air Conditioning

HVAC Installer Job at One Hour Heating and Air Conditioning

...Job Description Job Description One Hour Heating & Air Conditioning is Hiring HVAC Installers! Advance Your Career Earn $100K+ Annually ~401(k) with employer match ~ Generous Paid Time Off (PTO) & Paid Holidays ~ Uncapped Earning Potential ~ Career Growth...

Carters

Store Manager - 24H400 Job at Carters

...in the marketplace. These brands are sold in leading department stores, national chains, and specialty retailers domestically and internationally... ...is available at Walmart, its Just One You brand is available at Target, and its Simple Joys brand is available on Amazon. The Company...

Sodexo

Airport Lounge Wait Staff Job at Sodexo

...Location Name: LOT POLISH AIRLINES ORD - 95470001 Location ID: 95470001 Airport Lounge Wait Staff Location: LOT POLISH AIRLINES ORD - 95470001 Workdays/shifts : Afternoon/evenings - varying days . More details will be provided during the interview process...

Abundant Solutions

Order Selectors $18 DOE Mid-Shift Job at Abundant Solutions

...Shift: Mid day! Key responsibilities of an order selector: Picking orders: Locate and retrieve products from designated warehouse... ...control: Inspect products for damage or defects before packing and report any issues. ~ Packaging and labeling: Properly...

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

NWcySXQ2N0FHL0tTdVR0KzJoZFZJdGVpT0E9PQ==