Manager/Sr. Manager, Regulatory Affairs

3 weeks ago

Oklahoma City, United States CareerBuilder Full time

All Jobs

>

Manager/Sr. Manager, Regulatory Affairs

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 Schrdinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Companys unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.
Morphic is advancing fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 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 BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.
Job Description:
The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of 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 the execution of 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 (as needed), and communicate information to key stakeholders.
Assist in the setup, management, and maintenance of the 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 people skills, and experience developing strategic, and long-term relationships with key stakeholders.
Strong organizational, problem-solving, and analytical skills, as well as the ability to multi-task.
Demonstrated ability to clearly communicate the 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 multidisciplinary team, and with external parties.
Strong team player who 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 RIMS experience is a plus.
Qualifications:
Required
BS or MS with at least 4 years of direct experience in Regulatory Affairs in the pharmaceutical/biotech industry.
Strong knowledge of FDA regulations is required.
An understanding of ICH, EU and other rest of world (ROW) regulatory requirements is preferred.
Experience in managing the preparation of regulatory documents including individual modules of a new IND, 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 programs is a plus.
Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.
Knowledge of GMP, GLP and GCP regulations and clear understanding of the pharmaceutical product life cycle.
A three-day per week onsite presence is required for effective team interaction.
Cultural Fit:
Our culture is collaborative, one where people enjoy coming to work. We are a small, entrepreneurial company where everyone pitches in and works together to do whatever it takes to get things done. Our team is passionate, enthusiastic, and committed. We have a fast-paced, high accountability environment. We have a flat organization, and our leaders lead through influence and
interpersonal skills, not command and control. Everyone on the team, including our CEO, is an individual contributor. We seek an individual for this position who shares our values and our enthusiasm about bringing new medicines to the patients and families that need them. We seek someone who will enjoy working in a small company environment and be motivated by the opportunity to directly influence and help shape the future direction and culture of our company.
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.

#J-18808-Ljbffr

  • Sr Director, Regulatory Affairs

    3 weeks ago

    Oklahoma City, United States HireMinds Full time

    Our cutting-edge, vaccine client is seeking a Sr. Director, Regulatory Affairs (REMOTE) to their growing team! This role will be accountable for developing regulatory strategies for their vaccine candidates with an emphasis on European requirements for early and late-stage assets. This person will be a key regulatory leader who partners with internal and...

  • Director Regulatory Affairs-CMC

    1 week ago

    Oklahoma City, United States Disc Medicine Full time

    Disc Medicine is seeking a Director, Regulatory Affairs-CMC to serve as the Regulatory-CMC lead for Disc Medicine’s small molecule program pipeline. This position will have close collaboration with the development teams and visibility to the executive leadership with meaningful opportunities for professional development and career growth.The position...

  • Associate Director Regulatory Affairs Ad Promo

    6 days ago

    Oklahoma City, United States EPM Scientific Full time

    Title: Associate Director, Regulatory Affairs Advertising & Promotion The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products...

  • International Regulatory Affairs Specialist

    4 weeks ago

    Salt Lake City, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description What will be your activities at bioMrieux?The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist to support Latin America & Canada region in a dynamic regulatory context.The Regulatory Affairs Market team composed of 9 people is in daily contact with the local regulatory teams (subsidiaries and distributors) in order...

  • Regulatory Affairs Intern

    1 week ago

    Jersey City, United States Noven Pharmaceuticals Full time

    Overview: Undergraduate or Graduate student in a Science discipline. This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group. He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects....

  • Regulatory Affairs Intern

    7 days ago

    Jersey City, United States Noven Pharmaceuticals, Inc. Full time

    Undergraduate or Graduate student in a Science discipline.  This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group.  He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects.  Additionally,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Daly City, United States CareerBuilder Full time

    Responsibilities: Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation....

  • Regulatory Affairs Intern

    7 days ago

    Jersey City, United States Noven Pharmaceuticals, Inc. Full time

    Undergraduate or Graduate student in a Science discipline.  This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group.  He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects.  Additionally,...

  • Regulatory Affairs Intern

    2 weeks ago

    Jersey City, New Jersey, United States Noven Pharmaceuticals Full time

    Overview: Undergraduate or Graduate student in a Science discipline.  This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group.  He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects. ...

  • Sr Marketing Manager- Microbiology

    6 days ago

    Salt Lake City, United States BIOMERIEUX, INC. Full time

    Sr Marketing Manager- Microbiology Location: Field, UT, United States Position Type: Unfixed Term Job Function: Marketing Share: A family-owned company, bioMerieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve...

  • Executive Director, Medical Affairs

    1 week ago

    Oklahoma City, United States Morphic Therapeutic Full time

    Description 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 Schrödinger, Morphic is advancing its pipeline and discovery...

  • Government Affairs Manager

    7 days ago

    City of Industry, United States Athens Services Full time

    The Government Affairs Manager will report to the Vice President of Government Affairs and will support the Director of Government Affairs in the Athens West cities serviced out of the Los Angeles North (LANO) office. In this position, the successful Government, Manager, Vice President, Airline, Business

  • VP, Regulatory Affairs Specialist

    6 days ago

    Jersey City, NJ, United States Jefferies Financial Group Full time

    Regulatory Affairs SpecialistPosition This hire will be a member of the Firm’s Regulatory group which is responsible for exam oversight, branch inspections, regulatory change tracking, governance related tasks and additional ad-hoc tasks.  The Firm’s Regulatory Group is housed within its Legal Department.  While attorneys are encouraged to apply,...

  • Community Affairs Manager

    4 weeks ago

    Oklahoma City, United States OG&E Full time

    JOB SUMMARY Responsible for developing and maintaining positive working relationships and to support and help advance the company's business strategy by fostering the support of citizens, businesses, organizations, elected officials and its members throughout the company's service territory and to represent the communities' needs to the...

  • Community Affairs Manager

    3 weeks ago

    Oklahoma City, Oklahoma, United States OG&E Full time

    JOB SUMMARYResponsible for developing and maintaining positive working relationships and to support and help advance the company's business strategy by fostering the support of citizens, businesses, organizations, elected officials and its members throughout the company's service territory and to represent the communities' needs to the company.LEVEL OF...

  • Lead Consultant, Regulatory Consulting/Life Sciences

    2 weeks ago

    Oklahoma City, United States Clarivate Full time

    Clarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. Our connected data, deep expertise and intelligence platforms empower life sciences and healthcare companies to...

  • Director, Medical Affairs Operations

    2 weeks ago

    Foster City, United States Mirum Pharmaceuticals Inc Full time

    MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into...

  • Sr Quality Assurance Manager

    2 weeks ago

    Oklahoma City, United States Brunel Full time

    Position Overview: Brunel is seeking a highly skilled and experienced Senior Manager of Quality Assurance to join our MA-based client. The Senior Manager of Quality Assurance will be responsible for overseeing all aspects of quality assurance activities related to the design, development, manufacturing, and distribution of their Class II medical devices....

  • Sr Manager of Manufacturing Engineering

    2 weeks ago

    Oklahoma City, United States Mosaic Personnel Full time

    Job DescriptionJob DescriptionWhy You'll Love This Sr. Manufacturing Engineering Manager RoleLead the charge in optimizing manufacturing operations, with a focus on efficiency, quality, and safety, in a dynamic and innovative environmentMentor and coach cross-functional teams to implement best-in-class solutions, fostering a culture of continuous...

  • Sr Manager of Manufacturing Engineering

    1 week ago

    Oklahoma City, United States Mosaic Personnel Full time

    Job DescriptionJob DescriptionWhy You'll Love This Sr. Manufacturing Engineering Manager RoleLead the charge in optimizing manufacturing operations, with a focus on efficiency, quality, and safety, in a dynamic and innovative environmentMentor and coach cross-functional teams to implement best-in-class solutions, fostering a culture of continuous...