Regulatory Project Manager (Orphan Drug; US, ROW) – Remote/Top $$

Our client, an emerging biotech that is developing life-saving antidotes for venomous snakebites, is actively recruiting for a highly skilled Regulatory Affairs professional to join its outstanding team.

There is intense global need for affordable, accessible, oral treatment for snakebites, which disproportionately affects the most vulnerable populations.  Our client, a public benefit biotech company, has received FDA Fast Track designation for its lead product and has recently successfully closed its Series B financing.

Having the right person in place to manage all Regulatory efforts is essential.  The company will offer generous wage (plus bonus and equity) to attract and retain a star.

Key Things to Note:

• This is a virtual company.  The role is fully remote, and candidate can be located anywhere in the US.
• The company is seeking new drug approval in the US as well as Africa and India.  Seek candidate with global RA experience.  Knowledge of ROW regulatory strategies, standards and best practices will be important. Orphan Drug experience would also be valuable
• To date the company has engaged outside consultants for all Regulatory needs.  Going forward, consultants will continue provide strategic guidance and will partner with this RA Project Manager (client is also open to Sr Manager and Director candidates), who will lead internal management of all Regulatory efforts.  Seek a strong and skilled collaborator.
• Role will involve managing the efforts of numerous stakeholders to achieve regulatory success. We need an exceptional project manager with the demonstrated ability to keep all projects (and people) on track.
• This role will involve original writing as well as the review/editing of work of others.  Right candidate will bring a comprehensive understanding of regulatory writing best practices, strong technical writing skills, a keen eye for detail, and experience reviewing/editing the work of others. 
• This company is in high-growth mode but, in many respects, operates as a start-up.  Seek flexible, resourceful, versatile and can-do candidate who works through obstacles, clarifies ambiguity, is solutions-driven and stays goal-focused.
• Some travel may be required. 

 Selected Responsibilities:

• Manage the regulatory strategy through cross functional collaboration with internal and external stakeholders in various functional areas
• Partner with stakeholders to develop regulatory solutions that will enable the company to meet strategic goals for product approval in the US, India, Africa, and other areas globally
• Participate in development meetings, provide regulatory support and guidance, and manage day-to-day regulatory activities
• Guide team of consultants and CROs responsible for publishing and writing to accomplish drug development objectives; proactively communicate timelines and deliverables so that expectations are clear
• Guide internal stakeholders in writing and editing submissions
• Review and edit documents to ensure consistency and regulatory compliance.
• Manage updates to CMC, nonclinical, and clinical information included in regulatory submissions (e.g., IB, protocols, safety reports)
• Research and provide analysis of current global regulatory laws and guidelines; stay abreast of changes

 Targeted candidate will be a US Citizen who offers a BS/BA degree in Life/Health Sciences (advanced degree preferred) and 5+ years of experience in pharma/biotech regulatory affairs, including substantial experience in Regulatory Ops. Orphan Drug/Rare Pediatric Disease bkgd a plus.

 Other priorities include:

• Deep knowledge of current US regulatory guidelines; exposure to regulatory guidelines in India, Africa and ROW strongly preferred
• Outstanding organization and project management skills
• Excellent writing, review and editing skills; compliant and clean documents are a must
• Experience with eCTD structure and database management abilities including IND and NDA submissions
• Collaborative work style including demonstrated ability to coordinate the work of others in a virtual setting
• Strong communication, including the ability to present technical or complex material to less technical stakeholders
• Regulatory Affairs and Project Management certifications desirable

 Finally, we seek a candidate who will thrive in a small team, emerging business setting; someone who needs minimal direction, demonstrates job ownership, adapts readily to changes or unexpected occurrences, and is mission-driven.

 This company is doing important, revolutionary, impactful work.  We seek a Regulatory Affairs professional who is ready and able to significantly contribute to its success.

 Please forward resume or CV for prompt consideration.