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Sr. Director, Regulatory Affairs
Enveda BiosciencesUnited Statesfull_timeVerifiedPosted 9 Jan 2025
💰 $290,000/yr($260,000/yr – $290,000/yr)
About the role
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 Head of Early Development to contribute to our mission of advanced drug discovery by developing a regulatory strategy, including multiple different paths 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.
You will report to and work with our Head of Early Development.
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 our 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 you to do your best work.
Enveda's values
Curiosity: Learn and challenge. Agency: Own and initiate. Journey: Love the process.Charity: Take care of each other.Unity: We are one Enveda.
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. Unity is a
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 Head of Early Development to contribute to our mission of advanced drug discovery by developing a regulatory strategy, including multiple different paths 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.
You will report to and work with our Head of Early Development.
You get to collaborate on:
- Develop a strategy for navigating different agencies and regulatory pathways to determine which is best suited for each asset
- Provide regulatory strategy for trial design and regulatory agency expectations
- 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 IND and NDA packages
- Oversee preparation of regulatory documents
- Prepare and represent Enveda in meetings with Regulatory Authorities
- Work alongside other Enveda teams to ensure all regulatory requirements are met, including but not limited to, preclinical studies, toxicology, clinical, and CMC.
Who will thrive in this role?
- 5 - 10 years in FDA regulatory affairs for the biotechnology and or Global pharma
- Exceptional communication, both verbal and written
- Experience preparing and submitting FDA meeting requests
- Must have IND experience, NDA experience is desirable packages using the eCTD structure.
- If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.
What to expect in the interview process:
- HR Screen (30 minutes)
- Hiring Manager Interview (45 minutes)
- Technical Interview (45 minutes)
- Work Sample Interview (60 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. Company pays 90% of premium for employee and dependents
- 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.
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 our 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 you to do your best work.
Enveda's values
Curiosity: Learn and challenge. Agency: Own and initiate. Journey: Love the process.Charity: Take care of each other.Unity: We are one Enveda.
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. Unity is a
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