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Northeastern University · 3 months ago

Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow

Boston, MA

Full-time

Onsite

New Grad

$59K/yr - $84K/yr

Northeastern University is offering a two-year Regulatory Affairs PharmD fellowship in partnership with Ironwood Pharmaceuticals, a biotechnology company focused on developing therapies for gastrointestinal and rare diseases. The fellowship aims to train Pharm.D. graduates in Global Regulatory Affairs, preparing them for a career as individual contributors in the industry while providing hands-on experience in regulatory submissions and strategy.

Education

Growth Opportunities

Responsibilities

Assist in the planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registrations, and post marketing requirements and commitments

Assist in the development of regulatory strategies for assigned projects or product(s) across all phases of product development aimed at achieving marketing authorization and appropriate product labeling

Assist in planning, authoring, reviewing and preparing investigational new drugs (INDs) / clinical trial applications (CTAs), new drug applications (NDAs), Marketing Authorization Applications (MAAs), and related annual reports, amendments, supplements, and other activities required for life-cycle management of approved products

Support the preparation for regulatory agency meetings for assigned products, including meeting plan, development of briefing books, and ensuring submitted documents are compliant and of the highest quality

Work with Regulatory Operations team members to establish and meet timelines for regulatory submissions

Keep abreast of and communicate changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions

Support and participate in the development of Regulatory Department systems and processes

Assist with performance and compliance metrics for internal and external responsibilities

Collaborate with internal teams and vendors to prepare for inspections and audits

Present and assist in coordinating guidance reviews and other presentations

Interact with partners and engage in vendor oversight as required

Participate in fellowship recruitment activities and interviews

Additional responsibilities to be assigned based on individual interests or as business needs require

Qualification

Regulatory AffairsPharmDRegulatory strategyMicrosoft Office SuiteAnalytical thinkingCommunication skillsTime managementLeadership abilitiesInterpersonal skills