Regulatory Associate

3 weeks ago

Durham, United States eTeam Full time

POSITION TITLE: Regulatory Associate - US Country Labeling

DURATION: 1 YEAR (Potential for extension)

Location: Durham, NC

HYBRID: Min of 2 days on site - Day shift

Pay Rate Range: $30.71/hr on W2


• Preferred Degrees: Bachelors (or equivalent experience)


Job Responsibilities:

• Responsible for the production (authoring or assisting the authors), in terms of quality and regulatory acceptability of manuscripts for new/revised prescribing information for products marketed in the US.

• Identifies and resolves problems in a proactive manner.

• Suggests creative approaches to capture labeling concepts in a succinct manner.

• Ensures appropriate consistency in labeling documents across products for assigned area of responsibility.

• Works with Labeling Strategy staff to ensure compliance with US Labeling processes.

• Must be able to effectively articulate FDA and Client requirements for labeling documents to Client matrix teams, champion change, and recommend unique solutions, as needed.

• Ensures all labeling regulatory requirements associated with assigned products are met.

• Works with Matrix Team to resolve any labeling issues in a proactive manner.

• Ensures accurate version control of multiple labeling submissions and components.

• Develops FDA-compliant XML labeling documents for submission in accordance with Client or FDA timelines.

• Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML labeling.

• Produces all required versions of prescribing information documents for submission purposes and ensures all submission requirements are met for these documents.

• Completes all assigned tasks to project deadlines.

• Is able to manage own time at the task level and works on multiple projects in parallel.

• Provides summaries of Labeling updates as needed for NDA or BLA Annual Reports.

• The major outputs of this position are:

o Provision of Regulatory advice regarding prescribing information requirements to a range of development projects and more broadly across the Global Regulatory Affairs and Client Matrix Teams.

o Ensuring prescribing information for prescription products in the US meet all regulatory requirements.

o Production of FDA-compliant XML labeling documents.

o Ensuring proper version control of US prescribing information.


Competencies and Capabilities

• Demonstrates an understanding of regulatory labeling requirements for US prescribing information submissions, and a detailed understanding of internal policies, procedures, and guidelines. Uses this knowledge to initiate or provide input into the authoring of prescribing information, and to produce all required labeling documents for US submissions.

• Ability to work with project teams to resolve issues regarding prescribing information requirements.

• Effectively builds positive relationships within Labeling team and with other Client colleagues.

• Ability to identify issues and independently devise and implement solutions.

• Is considered authoritative source for FDA and Client requirements for prescribing information, including XML labeling.

• Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully.


Basic Qualifications:

• Undergraduate Degree in a Science or Life Science area preferred or equivalent practical experience.

• Labeling and Regulatory experience preferred.

• Knowledge of FDA regulations relevant to labeling, preferred.

• Proficient with computer software applications.

• Knowledge of XML labeling, preferred.

• Familiarity with medical terminology required.

• Ability to negotiate solutions to labeling issues.

• Ability to work on multiple projects with attention to detail.

• Excellent written and oral communication skills.

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