Director, Regulatory Affairs Strategy at BlueRock Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Cell Therapy, PharmaceuticalsIndustries

Requirements

Experienced and strategic in regulatory affairs
Expertise and knowledge of global regulations and guidance for the development of advanced therapies
Ability to lead global regulatory activities as Global Regulatory Lead on assigned program(s)
Highly cross-functional, with collaboration skills across Clinical, CMC, Nonclinical, Quality, and Program Management teams
Capability to shape regulatory strategy, lead health authority interactions, and support preparation/submission of regulatory documentation across development lifecycle

Responsibilities

Develop overall regulatory strategy for assigned programs, working closely with the nonclinical and clinical teams, in conjunction with the Regulatory CMC and Device leads
Provide regulatory leadership as the Global Regulatory Lead to program teams and subteams as the go-to point of contact for regulatory strategy on assigned program(s)
Lead the Regulatory Strategy Subteam(s) in the development of global regulatory plans to support assigned program(s)
Collaboratively identify regulatory risks to product development and design risk mitigation strategies as aligned with cross-functional SMEs
Provide regulatory support and contribute to the development and implementation of regulatory strategies to support the approval and commercialization of assigned products in compliance with applicable Health Authority requirements, including the identification of gaps or risks and opportunities to expedite development through innovative pathways
Collaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout the product lifecycle and to prepare for health authority meetings, clinical trial applications, and market applications in the US and ex-US territories
Guide and/or lead the generation of dossiers in conjunction with Regulatory CMC and Device colleagues to support Health Authority meetings, clinical trial applications, and market applications in the US and ex-US territories
Represent the Regulatory Affairs function on various subcommittees

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory StrategyHealth Authority InteractionsIND SubmissionsBLA SubmissionsCell Therapy RegulationsGlobal Regulatory AffairsClinical Regulatory Strategy

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What skills and experience are required for the Director, Regulatory Affairs Strategy role?

The role requires experience and strategic expertise in leading global regulatory activities, knowledge of global regulations and guidance for advanced therapies, and strong cross-functional collaboration with Clinical, CMC, Nonclinical, Quality, and Program Management teams.

What is the company culture like at BlueRock Therapeutics?

BlueRock's culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness. They seek collaborative individuals who thrive in a fun and dynamic culture and are committed to advancing cutting-edge cellular therapies.

What makes a strong candidate for this regulatory affairs role?

A strong candidate is experienced and strategic in regulatory affairs for cell therapies, with expertise in global regulations for advanced therapies, and excels in cross-functional collaboration and leading health authority interactions.

BlueRock Therapeutics

Develops advanced cellular therapies for diseases

About BlueRock Therapeutics

BlueRock Therapeutics develops advanced cellular therapies using a unique cell gene platform that directs cellular differentiation and genetically engineers cells. This technology allows them to create new types of medicines aimed at treating complex diseases in areas such as neurology, cardiology, and immunology. Their products work by transforming cells to target specific medical conditions, including neurodegenerative diseases, heart failure, and immune disorders. Unlike many competitors, BlueRock focuses on a specialized approach within the rapidly growing field of regenerative medicine, emphasizing strategic partnerships and research and development to advance their therapies. The company's goal is to address challenging medical conditions through innovative cellular treatments and to generate revenue through collaborations, licensing agreements, and eventual commercialization of their therapies.

Cambridge, MassachusettsHeadquarters

2016Year Founded

$218.9MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Hybrid Work Options

Risks

Competition from established firms like Johnson & Johnson may overshadow BlueRock's innovations.

Reliance on strategic partnerships poses risks if partners shift focus or resources.

Regulatory hurdles could delay product launches, impacting revenue and market position.

Differentiation

BlueRock uses iPSC technology to create novel cellular therapies for complex diseases.

Their strategic partnerships enhance R&D capabilities and expand therapeutic applications.

Focus on neurology, cardiology, and immunology addresses challenging medical conditions.

Upsides

FDA RMAT designation for bemdaneprocel accelerates market entry for Parkinson's therapy.

Successful Phase I trial of bemdaneprocel boosts investor confidence and funding potential.

Collaboration with bit.bio enhances discovery and development of new cell therapies.

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