Thursday, October 9, 2014

Vice President US Regulatory Affairs

Vice President US Regulatory Affairs

If you are an Executive, Director or VP with experience in US Regulatory
Affairs, please read on!

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.

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

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
- 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
- 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
- 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
- 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!

Executive, Director or VP with experience in US Regulatory Affairs.

SN2- -- in the email subject line

Stephen Niedringhaus | Executive Recruiter