Tuesday, October 14, 2014

Vice President US Regulatory Affairs

Vice President US Regulatory Affairs

Based in the emerging biotech hub of Dallas, we are a clinic-stage gene
therapy platform company establishing unique industry alliances to create
innovative treatments for people with unmet medical needs. Spinal muscular
atrophy (SMA) is our first focus. Collaborating with PBM Capital Group,
Roche Venture Partners, Deerfield Management, The Ohio State University,
Nationwide Children's Hospital and others, we have been able to gain
significant respect in the biotech community.

If you have the desire and ability to work in a fast-paced, start-up
environment we want to meet with you today!

Don't miss out on this great opportunity to make a difference. Interviews
going on NOW!
Top Reasons to Work with Us
- Cutting Edge Innovation
- Aggressive Compensation Structure
- Tremendous Opportunity for Growth

What You Will Be Doing
As Vice President of Regulatory Affairs you will be responsible for
overseeing all regulatory affairs activities across our gene therapy
portfolio.

You will be responsible for developing and leading the implementation of a
regulatory strategy to secure and maintain access for our products through
all development phases and through post-approval life-cycle management.

As Vice President of Regulatory Affairs, you will also be responsible for:

- Providing counsel, training and interpretation of FDA requirements to
company personnel
- Providing management and leadership to the organization in the
implementation of regulatory strategies to secure and maintain product
approvals
- Monitoring the regulatory landscape for competitive and/or similar
products and apply this knowledge to the development of our products
- Developing and maintaining relationships with FDA review staff; oversee
the management/conduct of regulatory interactions with FDA, assuring that
interactions are focused, amicable and documented
- Leading all of the regulatory affairs activities for the organization in
support of all internal and external programs in the portfolio
- Planning, scheduling and directing all regulatory activities and programs
- Preparing, reviewing and submitting all relevant regulatory documents to
the appropriate regulatory authorities
- Contributing regulatory input and consultation to project teams to ensure
compliance with regulatory guidelines and industry practice
- Preparing, reviewing and approving, as required, regulatory documents for
submission.
- Providing project plans and timelines in coordination with Program
Management for regulatory submission activities

What You Need for this Position
- Full functional knowledge of US regulations and guidelines pertaining to
the development and registration of drug products (medical devices
recommended)
- Proven ability to provide regulatory leadership and expertise within
cross-functional, team-based environment
- Strong collaboration and team-working, communication and organizational
skills required
- 10+ years Regulatory Affairs experience in a biotech, pharmaceutical
and/or academic setting
- Experience in communicating regulatory strategy, submission documents and
plans both internally and externally
- Experience in product development essential and gene therapy product
preferred
- eCTD familiarity preferred
- BS, MS or PhD in a scientific discipline

What's In It for You
- Aggressive Compensation Structure
- Very successful start-up with tremendous growth opportunity
- Vacation/PTO and much more!

Stephen.Niedringhaus@CyberCoders.com

SN2- -- in the email subject line

Stephen Niedringhaus | Executive Recruiter