Remote - Sr. Regulatory Affairs Associate - Pharmaceuticals

This position can be fully remote

PURPOSE AND SCOPE:

Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance.

Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US).

May act as FDA liaison for assigned projects.

Prepares for agency interactions by writing and organizing associated documentation, including letters and briefing packages.

Reviews and advises on manufacturing and control changes for marketed products, labels and clinical materials for products in development.

PRINCIPAL DUTIES AND RESPONSIBILITIES:


* Provides regulatory assessment and support.


* Evaluates and assesses regulatory impact of proposed product changes.


* Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development teams.


* Provides project team representation and direction in managing information from/to other departments regarding regulatory submissions.


* Support product development teams by interpreting and strategically applying regulations, guidances and available research/information.


* Plans, prepares and submits varied regulatory filings and correspondence to FDA and other appropriate Health Authorities.

Keeps to internal and federal timelines and ensures content, quality, accuracy and format of submissions comply with applicable laws, regulations and corporate standards.


* Critically reviews all types of documents for regulatory submission, including product labeling and promotional and advertising material.


* Conducts regulatory intelligence as required for in-licensing candidates and products in development.


* Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements.


* Maintains awareness of all current, pertinent regulations, guidelines, policies, procedures and practices.

Analyzes changes and updates and advises and provides recommendations to the department and interested personnel as needed.


* Participates in departmental continuous improvement activities.

Makes recommendations for process improvements for efficiency and accuracy of drug submissions and other processes.


* Enhances implementation of eCTD system by restructuring document format with new submissions.


* Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Networks with senior internal and external personnel in own area of expertise.  


* May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.


* May escalate issues to supervisor/manager for resolution, as deemed necessary.


* Mentor ...