-
Associate Director
1 week ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
4 days ago
Project Citizenship Boston, United StatesAre you passionate about positively impacting the lives of immigrants in Boston and beyond? Project Citizenship is seeking a dedicated Associate Director to join our dynamic team. As Associate Director, you will lead a core team of staff members and active volunteers, all committ ...
-
Associate Director
1 week ago
Lifelancer Boston, United StatesAbout the job Associate Director / Director AI Cheminformatics · Associate Director or Director, Cheminformatics · Cambridge, Massachusetts · Onsite, 1 day a week remote working · Generative AI, Drug Discovery, Pharmaceutical, Machine Learning, Artificial Intelligence · KEMI ...
-
Associate Director
1 week ago
Northeastern University Boston, United StatesAssociate Director – Lab Operations page is loaded · Associate Director – Lab Operations · Apply · locations · Boston, MA (Main Campus) · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R124701 · About the Opportunity · Responsibilities: · ...
-
Associate Director
1 week ago
Tufts University Boston, United StatesOverview · New Entry Sustainable Farming Project (New Entry) improves our local and regional food systems by training the next generation of farmers to produce food that is sustainable, nutritious, and culturally-appropriate and making this food accessible to individuals regardle ...
-
Associate Director
2 weeks ago
YMCA Boston, United StatesAssociate Director - Aquatics - Multiple Locations, Boston MA · Job Description · Associate Director - Aquatics - Multiple Locations · Boston, MA, US · Requisition ID: 1983 · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting i ...
-
Associate Director
5 days ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
2 weeks ago
AstraZeneca, plc Boston, United StatesIn this role, you will lead the design, development, and implementation of biopharmaceutical devices and will execute based on a deep understanding of engineering fundamentals, product requirements, and business needs. Typical development work includ Director, Device, Development ...
-
Associate Director
1 week ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
2 weeks ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
1 week ago
Environmental Economics, Inc. Boston, United StatesWhy You Should Join the E3 Team · When you join the E3 team, you will be working on some of the most important energy issues with some of the top minds in the electricity industry. We help shape energy and climate policy, play vital roles in regulatory proceedings, advise executi ...
-
Associate Director
1 week ago
Tufts University Boston, United StatesOverviewNew Entry Sustainable Farming Project (New Entry) improves our local and regional food systems by training the next generation of farmers to produce food that is sustainable, nutritious, and culturally-appropriate and making this food accessible to individuals regardless ...
-
Associate Director
1 day ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
2 days ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
2 weeks ago
Tufts University Boston, United StatesOverview New Entry Sustainable Farming Project (New Entry) improves our local and regional food systems by training the next generation of farmers to produce food that is sustainable, nutritious, and culturally-appropriate and making this food accessible to individuals regardless ...
-
Associate Director
4 days ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
20 hours ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
-
Associate Director
1 day ago
Tufts University Boston, United StatesOverviewNew Entry Sustainable Farming Project (New Entry) improves our local and regional food systems by training the next generation of farmers to produce food that is sustainable, nutritious, and culturally-appropriate and making this food accessible to individuals regardless ...
-
Associate Director
1 week ago
Tufts University Boston, United StatesOverviewNew Entry Sustainable Farming Project (New Entry) improves our local and regional food systems by training the next generation of farmers to produce food that is sustainable, nutritious, and culturally-appropriate and making this food accessible to individuals regardless ...
-
Associate Director
2 weeks ago
KPMG Boston, United States**Business Title:** Associate Director - Pricing Solutions (Professional Services Industry) · **Requisition Number:** · **Function:** Business Support Services · **Area of Interest:** · **State:** MA · **City:** Boston · **Description:** · Known for being a great place to work a ...
Regulatory Affairs Strategy Director or Associate Director - Boston, United States - Dennis Partners
Description
Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders.They are seeking a Regulatory Affairs Strategy Director or Associate Director who can develop and execute global regulatory strategy plans for their clinical-stage ophthalmology programs.
Reporting into the Chief Regulatory Officer, you will work closely with cross-functional teams and Health Authorities to achieve successful regulatory filings.
This company offers a science-based, entrepreneurial culture, excellent employee benefits, and flexible work arrangements. With their lead program going into global Phase three studies, now is an exciting time to join this growing organizationResponsibilities:
Assist the Chief Regulatory Officer in designing and implementing regulatory strategy plans for assigned ophthalmic drug programs.
Work closely and collaboratively with Regulatory Operations and Regulatory CMC to ensure high-quality and timely submissions to Regulatory Agencies including initial INDs, CTAs, NDAs, amendments, supplements, and Pediatric Study Plans.
Interface directly with US FDA and acts as primary liaison to FDA.Author health authority responses alongside subject matter experts, working with cross-functional teams through submission deliverables.
Review administrative forms, cover letters, general correspondences. Manage the routine maintenance of open regulatory applications.
Coordinate with Regulatory Operations and Regulatory CMC the submission planning of new applications, supplements or amendments and other regulatory filings both inside and outside the USA.
Work closely with Chief Regulatory Officer to prepare and facilitate informal and formal regulatory meetings aligned with established regulatory and development strategies.
Establish and maintain excellent working relationships and well-organized communications with US FDA representatives or other Health Agencies.In coordination with Chief Regulatory Officer, prepare regulatory risks assessment, and strategic plans, draft and maintain annotated labeling, and review for adequacy labeling components.
Assist the Chief Regulatory Officer in the Advertising and Promotional Review and submission (FDA 2253) process.Ensure that contents of submission are document are complete, accurate and compliant with health authority publishing specifications, the company style guide and template specifications.
Contribute to improvements in department best practices and SOPs.Performs other duties as required, interfacing with other departments, CROs, and external vendors.
Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
Archive and maintain regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs.This is a 'hands on' position where an individual must be versatile and capable of managing the operational workload that goes along with strategy execution.
Qualifications:
Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
Six or more years of Clinical Regulatory Affairs experience for pharmaceutical drugs or biologics.
Ophthalmology and/or Retinal disease experience highly desired.
Experience and knowledge in preparation of INDs, CTAs, NDAs and supportive amendments or supplements.
Must have experience working directly with the FDA and global regulatory authorities.
Experience with drug-device combination products desired but not required.
Working knowledge of eCTD elements and structure, ICH standards and submission requirements.
Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
Strong communication skills and strong regulatory writing skills.
Ability to balance multiple tasks to meet priorities and timelines.
Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
Able to be flexible and comfortable with ambiguity.
This is a hybrid/onsite position in the Greater Boston Area. This individual must be onsite 2-3 days a week.
The budgeted salary range for this position is US$180,000 to $240,000 plus an annual target bonus, equity, and comprehensive benefits.
Actual salaries may be based on a number of factors including, but not limited to, a candidate's skill set, experience, education, and other qualifications.
Posted salary ranges do not include incentive compensation or any other type of renumeration.#J-18808-Ljbffr
