(Sr) Director, Global Regulatory Strategy

Location
Cambridge, MA, United States
Posted
Aug 25, 2020
Ref
1329923541
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.

Reporting to the Vice President, Regulatory Affairs and Quality, the (Sr) Director of Regulatory Strategy will be responsible for the development and submission of regulatory filings for CRISPR/Cas9 based gene therapy projects, in the US and internationally. The individual will drive the development of innovative global regulatory strategies and the preparation and submission of high‑quality sections of briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs), in close collaboration with Nonclinical, CMC, Quality and Clinical teams, and external consultants and collaborators, as needed.

Responsibilities:
    • Provide global regulatory strategic leadership to support development of multiple, innovative gene therapy products for the treatment of severe genetic diseases.
    • Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provides knowledge and expertise to guide team in appropriate regulatory strategy.
    • Proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation.
    • Manage and implement planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US, EU, Japan, and ROW.
    • Accountable for all submissions and approvals for assigned project(s).
    • Direct point of contact with health authorities, lead and manage FDA/global health authority interactions/meetings for project responsibilities; prepare and submit responses to queries.
    • Drive adherence to global regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals.
    • Partner and work very closely with Nonclinical, CMC, Quality and Clinical to ensure achievement of submission deadlines and obtain timely approvals of clinical trial applications.
    • Monitor global regulatory guidelines and anticipate trends that impact the regulatory environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.


Qualifications:
    • Master's degree in life sciences in biochemistry, chemistry, biology or related. pharmaceutical fields including biochemical engineering; advanced degree desirable.
    • Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in Regulatory Affairs for biologics.
    • Experience interacting with regulatory health authorities and experience with submitting CTA/IND and BLA/MAA filings, ideally in an area related to gene therapy.
    • Strong knowledge of drug and biologics development regulations and guidelines including ICH, FDA, and EMA.
    • Excellent written and verbal communication skills, strong technical knowledge, including regulatory writing.
    • Strong leadership qualities including strategic thinking, innovation, mentoring, collaboration, etc.
    • Solid working knowledge of drug development process and regulatory requirements in US and EU. Japan, Canada, and ROW a plus.
    • Detail oriented; science-based reasoning skills.
    • Ability to work in a fast-paced, start-up environment.
    • Ability to work effectively in a collaborative team-oriented environment where results are achieved through influence and the incorporation of multiple points of view.
    • Independently motivated and results orientation.
    • Experience working with gene therapy products, RNA-based therapeutics and/or orphan drugs preferred.
    • Experience with FDA/EMA expedited programs a plus.
    • Travel Requirement: 10%.


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What Intellia Stands For:

At Intellia, our mission is to develop potentially curative genome editing treatments that can positively transform the lives of people living with severe and life-threating diseases.

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds...free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .