Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

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Job Description

The Senior Manager of Regulatory Affairs will assist in the development and implementation of regulatory strategies to advance Cogent’s precision kinase inhibitors in oncology and rare diseases. This individual will provide strategic input and regulatory support to cross-functional development teams. Working alongside senior Regulatory staff, this individual will be a key contributor to Cogent’s program and regulatory teams.

• Contribute the development of the long and short-term regulatory plans and lead the implementation of the regulatory activities;
• Responsible for day-to-day project management of regulatory aspects for clinical and non-clinical programs;
• Attend Cogent team meetings as a key regulatory voice providing guidance (e.g., protocol reviews, report reviews, development plans);
• Work on the preparation and timely submission of global regulatory documents and responses to queries from authorities (e.g., INDs, CTAs, NDAs, MAAs);
• Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies;
• Advise and support relevant functional area on compliance with regulatory requirements;
• Assists and attends regulatory authority meetings;
• Research and assess current and proposed regulatory, scientific and pertinent topics (i.e., external meetings, workshops and conferences).

Qualifications

• Bachelor’s degree required. Advanced scientific related degree is advantageous, but not required;
• Regulatory filing experience required (e.g, IND(s)/NDA(s)/BLA(s) or equivalent);
• Strong project management skills, with a track record of delivering high impact results required;
• Outstanding and versatile written and oral communication skills required;
• Experience in oncology and small molecule drug development preferred;
• Solid working knowledge of drug development processes and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements is highly valued but not required.

Additional Information

Cambridge, MA: Our Boston office is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

Boulder, CO: We are in the process of building a second location in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location, which will serve as the future home of Cogent’s discovery research organization.

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), unlimited time-off, a 401(k) plan, and commuter/parking benefits.

• Cogent is an equal opportunity employer
• Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals