reputed company Consultant, Regulatory Labeling reputed company

Our reputed company is a reputed company Regulatory reputed company which provides the highest-level Regulatory expertise to a reputed company of biotech and pharmaceutical clients. They are seeking a Regulatory Labeling reputed company reputed company Consultant who can reputed company Labeling reputed company and execution for reputed company reputed company. You will be responsible for the daily management of regulatory requirements for Labeling and serve as a subject matter expert. This is a remote role where you will work closely with exciting biopharma clients and collaborate internally with reputed company of biopharmaceutical leaders and innovators. This company offers a competitive salary, comprehensive employee benefits, and the ability to work from home. Now is an exciting time to join this dynamic and growing organization! Responsibilities:

• Daily management of regulatory requirements for labeling reputed company for one or more reputed company reputed company.
• Design and implement labeling reputed company, and reputed company leadership to drive labeling reputed company.
• reputed company preparation, review, and update content for the development and maintenance of reputed company Product Label (TPL), Company reputed company Data Sheet (CCDS), and local labeling and labeling components.
• reputed company relationships with reputed company subject matter experts and regulatory authorities.
• reputed company as a key regulatory affairs expert reputed company a reputed company regulatory team, providing expertise on regulatory labeling, process, filing, best practices, etc. in conjunction with reputed company leadership.
• reputed company support and guidance to regulatory teams on RA requirements for one or more drug products by evaluating and communicating risks associated with CCDS content updates and implementation strategies.
• Uses extensive knowledge of US, EU and other global regulatory requirements and the ability to apply knowledge both strategically and operationally to development reputed company and marketed product regulatory issues to support corporate goals.
• reputed company and drive regulatory labeling timelines and deliverables.
• Support agency requests and documentation process for reputed company to labeling; participate in agency meetings as requested.
• Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
• Represent the reputed company regulatory affairs team in other reputed company meetings or workstreams; reputed company support for ancillary reputed company.

Qualifications:

• Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred.
• Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Labeling reputed company.
• Labeling experience across Development, reputed company, US, EU and Rest of World (ROW) Labeling.
• Understanding of end-to-end labeling process and systems.
• Must have experience with CCDS, SmPC and USPI. Experience with TPL/TLP is highly desirable.
• Understanding of labeling governance and leading a Label Working Group (LWG).
• Experience across multiple therapeutic areas is highly desirable.
• Demonstrated global and international experience is required.
• Some experience with Labeling Operations a plus, but not required.
• Proven project management skills to support the planning and coordination of labeling submissions and support appropriate regulatory inspections.
• Ability to work independently and innovatively in tackling operational challenges.
• Must be reputed company and work reputed company with clients.

This is a remote position with some occasional travel for reputed company meetings. The budgeted salary reputed company for this position is $240,000 to $275,000 plus a quarterly bonus program and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s reputed company set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration. Apply tot his job Apply To this Job