About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.
Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.
· The Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross functional development teams to assist in communicating and executing on regulatory strategy and submission timelines.
· Manage document and submission preparation and timelines for regulatory submissions to the FDA, including INDs, DSURs, briefing documents, amendments, etc.
· Interface with external Regulatory Operations vendor to support submissions to FDA.
· Manage, track and file all required SAE reports to FDA in accordance with Agency guidelines.
· Liaise with CRO in the compilation of documents for ex-US health authority submissions including IMPDs, CTAs, amendments, aggregate safety reporting, and annual updates.
· Interpret and communicate regulatory guidance to internal stakeholders to execute program objectives in compliance with applicable regulations.
· Participate in cross functional sub-teams focused on execution of the regulatory strategy.
· Contribute to the development of department policies, procedures (RA SOPs) and best practices commensurate with the requirements of a rapidly growing company.
· Acquire and manage regulatory Intelligence, liaise with regulatory intelligence external vendors, and communicate the information to key stakeholders.
· Assist in the set up and management, and maintenance of regulatory information management system (RIMS) and support the Quality function with the implementation of a new quality management system (QMS).
Essential Job Functions:
The candidate must be able to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
· Excellent interpersonal skills, experience developing strategic, and long-term relationships with key stakeholders.
· Strong organizational, problem-solving, and analytical skills, as well as ability to multi-task.
· Demonstrated ability to clearly communicate status of work, issues that arise, and proposed solutions to challenges to manager, team members, and head of the department.
· Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external parties.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work in a fast-paced environment and meet aggressive timelines.
· Strong written and verbal communication skills, including some regulatory writing experience.
· Advanced knowledge of the Microsoft suite of tools including Word, Adobe, PowerPoint, Excel is required.
· Previous IQVIA RIMS experience is a plus.
· BS or MS with at least 4 years of direct experience in Regulatory Affairs within the bio-pharmaceutical industry. Strong knowledge of FDA regulations is a must. An understanding of ICH, EU and other rest of world (ROW) regulatory requirements is a bonus.
· Experience preparing and writing regulatory documents including individual modules of a new IND, safety reporting, new and updated Investigator Brochures, DSURs, IMPDs, CTAs, Orphan Drug applications, briefing packages and other regulatory submissions, in eCTD format.
· Experience with small molecule drug development is preferred.
· Experience with early development is a plus.
· Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.
· GMP, GLP and GCP regulations knowledge and clear understanding of the pharmaceutical product life cycle.
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives. In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.