Executive Director Regulatory Affairs Strategy
2 weeks ago
Summary/Scope:
A multifaceted Regulatory Affairs Team Leader role.
Will be a key member of regulatory leadership to ensure the development, implementation and alignment of US/ ex US regulatory strategy across projects within Retina / Ophthalmology.
Will represent the regulatory affairs function as a Core Member of Project Teams and be responsible for developing and implementing regulatory strategy (US and/or global) to achieve regulatory approvals and competitive product labels.
Core Responsibilities:
- With VP Regulatory Affairs, lead the development and maintenance of Regulatory Affairs practices and procedures at Ocular Therapeutix
- Responsible for preparation and compilation of domestic and international product submissions.
This may include, but is not limited to:
INDs, NDAs, MAAs, NDS and global CTAs. This also includes all lifecycle maintenance filings necessary to support these applications (e.g. CMC supplements/notifications, 2253 submissions, annual reports, efficacy supplements and safety reporting).
- Co-develop and direct implementation of global regulatory strategy for assigned projects, along with company representatives and other Regulatory and CMC staff.
- Guide regulatory staff in the development and implementation of regulatory strategy, submission strategy, and lifecycle management to ensure alignment with project team objectives (US and/or global).
- Communicate FDA feedback, regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment.
- Act as a strategic partner in the core governance & program teams within the company.
- Maintain knowledge of US competitive landscape, regulatory environment, regulations and guidances.
- Assesses the impact of new health authority guidances and provides insight and recommendations on Regulatory Policy & Intelligence
- Responsible for creation and maintenance of Regulatory Development Plans and submission strategies to achieve regulatory approvals that meet project needs.
- Lead the preparation of high quality regulatory dossiers ensuring compliance with regulatory requirements
- Ensure agency establishment registrations and device/drug listings are completed on time.
- Assist with the preparation and compilation of regulatory information requested during regulatory inspections.
- Support domestic and international field corrective actions and adverse event reporting, when necessary
Other/Related Responsibilities:
- Responsible for leading, managing, mentoring, and developing regulatory staff.
- Direct responses to Health Authority inquiries as needed.
- Review product and process documentation for assigned projects to ensure compliance with regulatory dossiers.
- Responsible for the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
- Provide regulatory research information as requested.
- Develop, review and secure necessary approvals on key documents before major regulatory submissions (US and/or global).
- May participate in Business Development/Strategic Alliances efforts.
- Lead or participate in regulatory sub-teams, FDA and other Health Authority meetings for a project, as required.
- Prepare management and team for FDA and other Health Authority meetings, as required.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances
Key Requirements:
- Solid scientific background, minimum Bachelors in scientific discipline. Advanced scientific degree, M.S. PharmD, PhD., M.D., preferred
- Minimum of 15 years pharmaceutical industry experience, of which 10 years in US and global regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting. Regulatory experience in multiple phases of drug development with deep expertise in Retina/Ophthalmology preferred.
- Demonstrated experience in strategic planning, preparing and leading IND/NDA submissions
- In depth knowledge of current US and global regulations and guidances essential as they relate to the overall global regulatory strategy
- Results driven and team-orientated with the ability to influence outcomes as necessary skills in the regulatory environment.
-
Director, Regulatory Affairs
2 weeks ago
Bedford, Massachusetts, United States Lantheus Medical Imaging Full timeJob Description Job Description Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.Lantheus is an entrepreneurial, agile, growing...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, Massachusetts, United States Werfen Full timeOverview WerfenWerfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.The Company's business lines include Hemostasis, Acute Care, and Autoimmunity...
-
Medical Director, Clinical Research
2 weeks ago
Bedford, Massachusetts, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
-
Director of Human Resources
2 months ago
New Bedford, Massachusetts, United States City of New Bedford Full timeThe Human Resource Director Role: Manage and supervise the HR Department to achieve strategic resource allocation goals Develop, guide, and propose executive management information and support needs Maintain and communicate records as required by law and local governing requirements The Director will plan, lead, direct, develop, and coordinate...
-
Pilot in Command Global 6500
4 weeks ago
Bedford, Massachusetts, United States Executive Jet Management Full timeTitle: Pilot in Command Global 6500Company: Executive Jet ManagementArea of Interest: CrewmembersLocation: Bedford, MA, US, 01730 Req ID: 13291Purpose of PositionExecutive Jet Management, a Berkshire Hathaway company, is seeking qualified candidates for a Global 6500 aircraft based at Bedford, MA (KBED). This is a three pilot account supported by a...
-
Health System Specialist
1 month ago
New Bedford, Massachusetts, United States Veterans Health Administration Full timeThe GHATP Trainee serves as a Health System Specialist within a one year formalized national training program. The GHATP training program is designed so that the incumbent acquires the knowledge, skills, abilities and competencies necessary to assume progressively more complex responsibilities and assist the Office of the Medical Center Director in...
-
Health System Specialist
2 weeks ago
New Bedford, Massachusetts, United States Veterans Health Administration Full timeThe GHATP Trainee serves as a Health System Specialist within a one year formalized national training program. The GHATP training program is designed so that the incumbent acquires the knowledge, skills, abilities and competencies necessary to assume progressively more complex responsibilities and assist the Office of the Medical Center Director in...
-
Health System Specialist
4 weeks ago
New Bedford, Massachusetts, United States Veterans Health Administration Full timeThe GHATP Trainee serves as a Health System Specialist within a one year formalized national training program. The GHATP training program is designed so that the incumbent acquires the knowledge, skills, abilities and competencies necessary to assume progressively more complex responsibilities and assist the Office of the Medical Center Director in...
-
Associate Director, Clinical Operations
2 weeks ago
New Bedford, Massachusetts, United States Progenics Pharmaceutical Inc Full timeJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.Lantheus is an entrepreneurial, agile, growing organization that...
-
Director, Global Benefits
2 weeks ago
Bedford, Massachusetts, United States Aspen Technology Full timeThe driving force behind our success has always been the people of AspenTech. What drives us, is our aspiration, our desire and ambition to keep pushing the envelope, overcoming any hurdle, challenging the status quo to continually find a better way. You will experience these qualities of passion, pride and aspiration in many ways - from a rich set of career...
-
Director, Tax
2 weeks ago
Bedford, Massachusetts, United States Aspen Technology Full timeThe driving force behind our success has always been the people of AspenTech. What drives us, is our aspiration, our desire and ambition to keep pushing the envelope, overcoming any hurdle, challenging the status quo to continually find a better way. You will experience these qualities of passion, pride and aspiration in many ways — from a rich set of...
-
Port Captain
4 weeks ago
New Bedford, Massachusetts, United States Hornblower Group Full timeSeaward Services is seeking a Port Captain for our Hornblower Wind CTV operation. About You: This person will be adaptable, dynamic, and embody City Experiences' RESPECT Service System. About the Opportunity: Under the supervision of the Program Manager, the Port Captain will be responsible for overseeing daily vessel operations. The position requires...
-
Port Captain
1 month ago
New Bedford, Massachusetts, United States Hornblower Group Full timeSeaward Services is seeking a Port Captain for our Hornblower Wind CTV operation. About You: This person will be adaptable, dynamic, and embody City Experiences' RESPECT Service System. About the Opportunity: Under the supervision of the Program Manager, the Port Captain will be responsible for overseeing daily vessel operations. The position requires...
-
FP&A Director
2 weeks ago
Bedford, Massachusetts, United States Novanta Full timeBuild a career powered by innovations that matter At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and...
-
Senior Manager, Field Communication
2 weeks ago
Bedford, Massachusetts, United States Werfen Full timeOverview WerfenWerfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity...
-
Director of Operations
2 weeks ago
New Bedford, Massachusetts, United States Better Community Living Full timeJob Details Job LocationGreater New Bedford Area - New Bedford, MA Position TypeFull Time Education Level4 Year Degree Job CategoryFinance Description 40 hours per week - Monday through Friday, with some flexibility We are seeking a dynamic Director of Operations Key Responsibilities:Family Support & Finance Departments (45%):Work collaboratively with the...
-
Associate Director, Customer Experience
2 weeks ago
Bedford, Massachusetts, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
-
Cook- The Residence at Bedford
2 weeks ago
Bedford, Massachusetts, United States LCB Senior Living, LLC Full timeJob DetailsJob Location The Residence at Bedford - Bedford, MA Description Unlock new career opportunities with LCB Senior Living at The Residence at Bedford Be among the first to join our exceptional team at our beautiful brand-new community. As we get ready for our grand opening, do not miss out on being a part of something special. At LCB, we're not just...
-
Journeyman Systems Engineer
2 weeks ago
New Bedford, Massachusetts, United States DCS Corp Full timeDCS Corp has an exciting opportunity for a Journeyman Systems Engineer to support the HBB/ Kessel Run (KR) Division, which is within the USAF Digital Directorate and located at Hanscom AFB, MA supporting Patriot Excalibur (PEX). PEX provides a multi-domain unit-level software toolset that enables Air Force, Joint Force and Foreign Military unit...
-
senior systems engineer
2 weeks ago
Bedford, Massachusetts, United States DCS Corp Full timeDCS Corp has an exciting opportunity for a Senior Systems Engineer providing support to the Air Force Life Cycle Management Center/PEO Digital Directorate (AFLCMC/HB). The Air Force Program Execution Office for PEO Digital (AFPEO/HB) has the collective Air Force Materiel Command (AFMC) mission responsibility to manage and execute the modernization,...