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Sr. Director, Regulatory Affairs

Enveda Biosciences

Enveda Biosciences

Legal
Remote
Posted on Thursday, January 18, 2024
Enveda is looking for a Sr. Director, Regulatory Affairs to join our team!
The contribution you will make:
As Sr. Director of Regulatory Affairs you will leverage your experience preparing IND and NDA packages to successfully bring drugs into the clinic and through marketing approval. You will be part of a diverse team reporting to the Chief Medical Officer to contribute to our mission of advanced drug discovery by developing a regulatory strategy, including multiple different paths (e.g., 505b1, 505b2, botanical) as well as preparing submission packages for regulatory agencies including FDA, EMA, and TGA (Australia). The role will require you to use your knowledge in FDA regulations and your creativity to develop strong submissions specifically for FDA pre-meetings and IND submission with unique strategies that take advantage of our platform and assets.
As a member of the Executive Team, you will report to and work with our SVP, Clinical Development.

You get to collaborate on:

  • Develop a strategy for navigating different agencies and regulatory pathways including 505b1,505b2, and botanical, in determining which pathway is best suited for each asset
  • Inform how ethnopharmacological evidence and other prior Real World Evidence and Real World Data - including proprietary Enveda data - can best be leveraged towards FDA approval
  • Prepare and submit of IND and NDA packages
  • Oversee preparation of regulatory documents including Investigator Brochures and Development Safety Update Reports
  • Prepare and represent Enveda in pre-meetings and meetings with the FDA
  • Work alongside other Enveda teams to ensure all regulatory requirements are met,including but not limited to, preclinical studies, toxicology, clinical, and CMC.
  • Oversee pharmacovigilance

Who will thrive in this role?

  • 5+ years in FDA regulatory affairs for the biotechnology and or supplement/cosmetic industry
  • Exceptional communication, both verbal and written
  • Experience preparing and submitting FDA meeting request, IND and NDA packages using the eCTD structure.
  • Experience and highly knowledgeable in the dermatology field

What to expect in the interview process:

  • HR Phone screen (30 minutes)
  • Hiring Manager Interview (45 minutes)
  • Technical Interview (45 minutes)
  • Work sample Interview (45 minutes)
  • Enveda Culture interview (30 minutes)

Some of the total rewards of working here:

  • Culture: Enveda lives for people
  • Salary: $260,000 - $290,000
  • Equity
  • Healthcare: Medical, dental and vision insurance. 90% coverage of employee premiums
  • 401k: Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation).
  • PTO: Flexible paid time off (that we encourage and celebrate). Company-wide weeklong break to recharge. 10 observed holidays.
  • Work-Life Harmony
  • Adoption Assistance: At Enveda we want to celebrate and support employees who want to adopt children. We're excited to offer adoption assistance to employees who have completed the adoption process, including placement.
Come join us!
Our employees are the lifeblood of our work and our inspiration to press on. Together we've built a special place here—a drug discovery platform that's unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you.
Employee Promise
Using imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling each of us to do our best work
Enveda's values
• Don't rush, but don't wait. • Over-communicate and follow up by default. • No question or comment is incorrect, silly, or basic. • Listen to, learn from, grow with, and help grow your team. • Always say what you really think - with positive intent. • Be an Intrapreneur. • Celebrate your wins, and also your failures. • We are One Enveda. • Be courageous.
We value your uniqueness
One of life's gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles.
Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. One-Enveda is a company value because success depends on trusting, working relationships that respect the commonality and differences of people.
At Enveda we are building a place where every person can do the best work of their lifetime.
Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws.
*Please note jobs may be taken down from our website, this does not mean they have been filled. This is to maintain our candidate experience for current applicants. If you are in the interview process and would like to request a copy of the job description, reach out to your recruiting contact.