Manager/Sr. Manager, Regulatory Affairs

1 month ago

Waltham, United States Planet Pharma Full time

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:

• 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:

• 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.

  • Manager, Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.  This...

  • Manager/Senior Manager, CMC Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Great Science.Deep Compassion.Real Impact.Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction.We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio...

  • Regulatory Manager

    1 day ago

    Waltham, United States BostonGene Full time

    Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Senior Director, Clinical Regulatory Affairs

    2 weeks ago

    Waltham, United States Dragonfly Therapeutics, Inc. Full time

    Senior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects,...

  • Director, CMC Regulatory Affairs

    1 month ago

    Waltham, United States Alkermes Full time

    Overview: Great Science. Deep Compassion. Real Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases....

  • Senior Director, Clinical Regulatory Affairs

    3 weeks ago

    Waltham, United States Dragonfly Therapeutics Full time

    Senior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects,...

  • Director, CMC Regulatory Affairs

    1 month ago

    Waltham, Massachusetts, United States Tscanrx Full time

    We are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan's oncology...

  • Regulatory Manager

    1 month ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Regulatory Manager

    4 weeks ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Regulatory Manager

    4 weeks ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Director, CMC Regulatory Affairs

    1 day ago

    Waltham, United States Alkermes Full time

    Job Description Overview: Great Science. Deep Compassion. Real Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat...

  • Director, Regulatory Affairs

    4 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Director of Regulatory Affairs

    4 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director, Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Sr. Manager GCP quality Assurance

    7 hours ago

    Waltham, United States Planet Pharma Full time

    Job Description: Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations,...

  • Sr. Manager GCP quality Assurance

    2 days ago

    Waltham, United States Planet Pharma Full time

    Job Description:Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations,...

  • Sr. Manager GCP quality Assurance

    21 hours ago

    Waltham, United States Planet Pharma Full time

    Job Description:Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations,...

  • Sr. Director, Clinical Regulatory Affairs

    4 weeks ago

    Waltham, United States ClinCrowd Full time

    Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory strategies to obtain and maintain clinical...

  • Sr. Director, Clinical Regulatory Affairs

    4 weeks ago

    Waltham, United States ClinCrowd Full time

    Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory strategies to obtain and maintain clinical...

  • Sr. Director, Clinical Regulatory Affairs

    4 weeks ago

    Waltham, United States ClinCrowd Full time

    Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory strategies to obtain and maintain clinical...