Pharmaceutical Clinical Associates, LLC
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Union ,
NJ
For all assigned products:
-Represent Regulatory Affairs as a member of Forest Project Teams
-Provide regulatory strategy to teams and management towards the filing and approval of INDs and NDAs
-Actively monitor and advise applicable team members and product managers of upcoming regulatory affairs deadlines and other critical dates (e.g. patent expiration)
-Proactively solicit regulatory submittals from other company departments including: preclinical, clin/pharm, clinical development, commercial (marketing), and manufacturing.
-Assure the proper management, retention, and version control of all applicable Regulatory Affairs and product documentation.
-Coordinate activities for paper-based and electronic submissions with applicable regulatory agencies. Prepare submission packages and on approval, submit materials to applicable agencies.
-Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs.
-Identify areas for improvement within daily functions, internal procedures, and regulatory agency interaction.
-Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions.
-Prepare applicable management reports related to assigned products.
-Maintain a high level of expertise through reading and participation at professional seminars,workshops.
-Exercises outstanding judgment in all areas of responsibility.
Experience and Skills:
Requirements
Education:
-Bachelors Degree in life sciences required.
-Advanced Science Degree or equivalent experience preferred.
Experience:
-Regulatory, professional with a minimum of 3 - 5 years of Pharma and regulatory affairs experience, including IND and NDA filings.
Basic understanding of the following functional areas (within the context of regulatory affairs):
- Quality Assurance
- Labeling
- Promotion
- Drug Safety
- Licencing
- CMC
Licensure/Credentials:
RAC certification a plus
Knowledge, Skills, and Abilities
Technical Qualifications:
-Knowledge of all relevant pharma regulatory procedures and reporting requirements
-Experience with document management of INDs, IND Amendments, FDA Briefing Packages, and NDAs. -Experience with CTD and e-NDA/e-CTD preparation preferred.
Strong technical background including proficiency in Windows, Microsoft Office Suite, and Documentum
General Qualifications:
-Superior communication skills in a team-based environment
-Energetic, self-motivated, organized individual who is accustomed to working in deadline-focused, high-pressure
entrepreneurial environment.
-Ability to manage multiple simultaneous products/projects.
-Proficiency in both written and verbal communications and presentations
-Strategic, analytical thinker with strong business acumen
-Proactive, disciplined, organized, and detail-oriented.
-Demonstrates consistent logic, rationality, and objectivity when identifying significant problems and opportunities.
-Creative problem solver with the ability to establish systems and define standard practices.
-Displays high level of integrity by remaining consistent in terms of what he/she says and does in terms of behavior toward others.
-Willing team player capable of working collaboratively with colleagues in their department and in all functions
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Union , NJ
Union , New Jersey
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