Senior Manager, Regulatory Affairs

Infinity Pharmaceuticals, Inc. Cambridge , MA 02138

Posted 4 weeks ago


Why Join Infinity:

We are a passionate, fun, and innovative team dedicated to advancing novel medicines for people with cancer. We are developing IPI-549, a first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition. In the first half of 2019, we intend to advance IPI-549 into MARIO-275, a global, randomized study evaluating IPI-549 in combination with OPDIVO (nivolumab) in I/O-nave urothelial cancer patients in collaboration with Bristol Myers Squibb. In the second half of 2019, we plan to initiate MARIO-3, the first IPI-549 combination study in front-line advanced cancer patients, as well as complete enrollment in the expansion cohorts of MARIO-1, our Phase 1b study of IPI-549. MARIO-3 will evaluate IPI-549 in combination with Tecentriq and Abraxane in front-line triple-negative breast cancer and in combination with Tecentriq and Avastin in front-line renal cell cancer.


The Senior Manager of Regulatory Affairs will be responsible for publishing and submitting electronic regulatory submissions as well as the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing and document management. This individual will act as the primary point of contact and be responsible for the management of any vendors which support the regulatory submission process. In addition to assigned projects, responsibilities include the ongoing evaluation of processes and systems relative to industry best practices, resource management and ensuring compliance with evolving U.S. and international regulations and guidelines. This person will have the opportunity to identify greater efficiencies, as well as manage and implement process improvements including training personnel.


Your Role:

  • Coordination, preparation, and submission of regulatory submissions to health authorities including FDA, EMA and other national authorities to support clinical trials, including original IND/CTA submissions, new protocols, protocol amendments, safety reports, new investigator information, and annual reports

  • Provide regulatory support to the clinical study teams (review clinical protocols, informed consent forms, Investigator's Brochures, and site documentation)

  • Coordinate and prepare responses to requests for information from health authorities

  • Represent Regulatory Operations on assigned teams to support submission scheduling and ensure coordination of system development activities

  • Manage vendor relationships related to regulatory operations activities

  • Act as the primary representative with consultants for CMC regulatory matters.

  • Develop and implement processes related to submission standards, working practices, and quality controls

  • Conduct cross functional training on submission standards, procedures, and systems as needed

  • Support compliance with worldwide submission regulations and guidelines


Requirements and Qualifications:

  • A BA/BS degree in life sciences or health related discipline or equivalent experience

  • 5-7 years of global regulatory operations experience; 10+ years of total biotech/pharmaceutical or related industry experience preferred

  • 5-7 years of experience compiling electronic submissions and electronic publishing

  • Experience compiling IND, NDA, and other CTD submissions

  • General knowledge of regulatory CMC

  • Demonstrated skills managing project timelines and organizing resources

  • Strong attention to detail and the ability to manage multiple tasks

  • Extensive experience using electronic document management systems. Experience with Microsoft Sharepoint a plus

  • Demonstrated ability to work well with cross functional teams

  • Strong leadership and communication skills and ability to work independently

  • Title will be commensurate with experience

What's it like to work with us? We believe that the energy of our culture and wellbeing of our team drives the passion behind our work. So, here's how we cultivate our culture and wellbeing:

  • We like to eat: You'll find a nicely stocked kitchen, weekly catered lunches, happy hour socials, and potluck Fridays, as well as offsites centered around good food

  • We like to play: Social and team-building events are planned throughout the year

  • We've got your covered:

  • Medical coverage offered through BCBS (HMO/PPO) with 100% premium covered by Infinity as well as BCBS dental plan and vision plan offered through VSP

  • Flexible Spending Accounts for medical expenses and dependent care expenses

  • Health Savings Accounts for those enrolled in our PPO plan

  • Other insurance protections paid by Infinity, including: life insurance, short-term and long-term disability

  • Balancing work and life:

  • A four-week paid sabbatical every five years with us

  • Summer Friday hours

  • 17 paid holidays including the week off between Christmas and New Year's Day

  • 15 vacation days increasing to 20 days over time

  • Competitive compensation and financial support:

  • Competitive base salary, annual merit-based cash bonus program, and stock option program

  • 401(k) plan with 100% company match on first 6% deferred, vested immediately

  • First-time Homebuyer Assistance Program

  • Subsidized parking or T/Commuter Rail pass

  • Voluntary auto/home Insurance discounts, Bluebikes discounts, employee assistance program, legal assistance program

  • Tuition Reimbursement Program

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Senior Manager, Regulatory Affairs

Infinity Pharmaceuticals, Inc.