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Job: Regulatory Affairs Manager/Director, Mycovia Pharmaceuticals, Inc., Durham, NC

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General Information


Job title:
Regulatory Affairs Manager/Director
Job location:
Durham, NC  27703 United States
Requisition code:
Date posted:
05/20/2019
Compensation:
Job category:
Regulatory Affairs
Employment type:
Full time

Job Description


Mycovia Pharmaceuticals has a passion for developing breakthrough therapies in women's health and areas of unmet medical need. Our lead product candidate, VT-1161, is a novel, oral therapy designed to have greater selectivity, fewer side effects and improved potency than current treatment options. It received FDA Qualified Infectious Disease Product and Fast-Track designations to support its potential as the first FDA-approved treatment for recurrent vulvovaginal candidiasis (RVVC). For more information, please visit www.mycovia.com

We are seeking a Regulatory Affairs Manager who will be responsible for managing efforts to meet the company’s regulatory objectives.

***Depending on experience of the selected candidate, leveling for this position may be adjusted to Senior Manager or Director level.***

This position is office-based; local candidates should apply.

Specific job responsibilities include:
• Author and serve as primary reviewer for US regulatory applications and documents for INDs, NDAs, ODAs, annual reports, designation requests, and briefing documents
• Manage regulatory correspondence and submissions documentation
• Generate and direct the preparation of submissions to regulatory authorities
• Plan and participate in meetings with regulatory agencies
• Coordinate internal response preparation to regulatory agency requests
• Perform regulatory intelligence research to evaluate regulatory pathways and precedents, interpreting regulations and guidance documents for project team
• Serve as point of contact for clinical team members advising on GCP and regulatory standards
• Prepare for and participate in regulatory inspection activities
• Provide input to strategic R&D planning with emphasis on regulatory pathways and development
• Review, establish, and update templates, work instructions, and SOPs
• Support corporate due diligence activities including evaluation and assessment for potential partnerships or product acquisition
• Support alliance management efforts with global partners
• Other duties as assigned by senior management

Job Requirements


Candidates are required to have 5+ years’ regulatory drug development experience in the pharmaceutical, biotechnology, or CRO industries and a minimum of a B.S. in biological/physical sciences or relevant discipline.

Desired candidates should:
• Possess good working knowledge of FDA regulations and ICH standards including GCP
• Be experienced with FDA submissions in eCTD format and FDA interactions/meetings
• Be flexible and adaptable to change in a fast paced, small company environment
• Have superior organizational skills, prioritization, and excellent attention to detail
• Work independently with little supervision
• Think strategically and analytically across development program
• Effectively communicate (both written and oral) with all levels and groups of the organization, regulators, external vendors, consultants, and collaborators
• Have strong interpersonal skills for teamwork
• Demonstrate success at delivering quality work products while meeting timelines in a fast-paced environment
• Have experience with NDAs, promotional materials, and post-approval lifecycle management (desirable but not required)

https://www.mycovia.com/privacy
(Job number: 3840751)
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