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Dyne Therapeutics Inc
Waltham, MA, United States
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
Job Source: Dyne Therapeutics IncAzurity Pharmaceuticals - US
Winchester, MA, United States
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad com
Job Source: Azurity Pharmaceuticals - USApellis Pharmaceuticals
Waltham, MA, United States
Position Summary: The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). Key Responsibilities Include: Ensure alignment of global regulatory strategies with Apellis corporate objectives. Collaborate wit
Job Source: Apellis PharmaceuticalsRapport Therapeutics
Boston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition
Job Source: Rapport TherapeuticsJRG Partners
Boston
Job Description Job Description Job Title: Director of Regulatory Affairs Job Description: As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that our products comply with all applicable regulatory requirements and standards. Leveraging your extensive knowledge of regulatory processes,
Job Source: JRG PartnersICAD, Inc
Nashua
Job Description Job Description DIRECTOR, REGULATORY AFFAIRS About iCAD: iCAD, a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’
Job Source: ICAD, IncDyne Therapeutics Inc
Watertown, MA, United States
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 muscl
Job Source: Dyne Therapeutics IncX4 Pharmaceuticals
Boston, MA, United States
Director, Regulatory Affairs Reporting to: Vice President, Regulatory Affairs Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatment
Job Source: X4 PharmaceuticalsBillerica, MA, United States
Great opportunity to use your regulatory expertise and lead a truly exceptional team!
As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships.
You will:
Foster professional growth and development for your direct reports
Use your extensive Regulatory and product development clinical and non-clinical strategy experience for all phases applications in the US and Canada.
Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on regulatory guidelines and requirements.
Interact with various stakeholders, including the writing team, subject matter experts, project leadership, and the Sponsor with a focus on high-quality deliverables.
Assist your team, as needed, in the development of regulatory submission strategies.
Utilize expertise to create efficient workflows and timelines.
Provide support to your team and utilize your expertise in regulatory writing to produce high-quality documentation for regulatory submissions.
Ensure high-quality deliverables by coordinating with the writing team, subject matter experts, project leadership and Sponsor.
Demonstrate strong project management skills to ensure on-time and high-quality project delivery.
Facilitate effective coordination and communication between stakeholders to achieve project goals.
Collaborate with cross-functional teams to ensure alignment of regulatory strategy with overall product development goals.
Implement strategies to mitigate risks and address potential challenges in project execution and staff allocation, resourcing needs.
Facilitate staff development plans and coordinates with project staffing for appropriate utilization and skill expansion.
Participate in project scoping calls, proposal preparation, and account planning for key clients.
Actively prospect and leverages new business opportunities in collaboration with Account Management
Communicate organizational vision and values to staff and promotes effective information flow.
Skills:
Management and leadership skills with proven experience coaching, motivating, developing, and retaining high performing regulatory professionals.
Consulting skills
Project management knowledge
Influencing others
Client-focused approach to work
Networking
Results orientation
Business analysis
Excellent interpersonal and intercultural communication skills, both written and verbal Teamwork and collaboration
Critical thinking and problem-solving skills
Holding people accountable
Operational leadership
Leading change
Strategic business thinking
Strong organization and planning skills with an attention to detail and ability to handle multiple tasks with accuracy.
To ensure success, you will have:
Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD) Preferred
10-15 years related Regulatory Affairs experience in the life sciences or consulting industries. Previous CRO or Consulting experience highly preferred
8+ years of experience in people management and leadership experience within the clinical and/or nonclinical regulatory functions
#LI-REMOTE
Email Alert for Director, Regulatory Affairs jobs in Billerica, MA, United States
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