Regulatory Affairs Senior Associate

Advanced Bio-Logic Solutions Corp Newbury Park , CA 91360

Posted 3 weeks ago

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Description:Note:REMOTE - no time zone preferenceWhat are the hours/schedule the contractor will be expected to work?Monday-Friday 8-5 PM, with the ability to support Pacific Time zone based on business needs in the evenings.Ideal Candidate:

Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA.
Degree in life sciences is also the preferred academic background.
Good communication skills - both oral and written.
Ability to understand and communicate scientific/clinical information, Organizational skills.
Knowledge of clinical regulatory submissions including IND, sIND, BLA, and sBLA useful. Use of document archival systems/electronic document repositories also useful.
Coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
Management and execution of the preparation, delivery and electronic archiving of documentation for inclusion in regulatory submissions.
Coordination and execution of regulatory affairs processes and deliverables.
Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory documents.

Technical:

Proficiency in Microsoft Suite (Outlook, Word, Excel, PowerPoint) Technical competency for data entry into electronic document management systems, SharePoint sites and other databases/trackers.

Preferred Skills:

Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to deal with ambiguity
Organizational savvy
Negotiation skills

Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Top 3 Must Have Skill Sets:

Use of document archival systems/electronic document repositories (Veeva RIM)
Knowledge of FDA clinical regulatory submissions including IND, sIND, BLA, and sBLA
Self-regulating prioritization and time management skills.

DAY TO DAY RESPONSIBILITIES / FIRST 30 DAYS:

Previous Regulatory Experience. Knowledge of FDA. Degree in life sciences. Good communication skills - both oral and written.
Ability to understand and communicate scientific/clinical information, Organizational skills. Knowledge of clinical regulatory submissions including IND, sIND, BLA, and sBLA useful. Use of document archival systems/electronic document repositories also useful.

Pay Rate - between $39 - $43/Hr on W2 based on experience."This posting is for Contingent Worker, not an FTE"

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