- Creating, reviewing, and contributing, and editing submissions to support development including US Investigational New Drug (IND) submissions, Canadian and EU Clinical Trial Applications (CTAs).
- Ensuring appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds.
- Travel occasionally for meetings and conferences.
- Keep up to date with regulations and guidance, interpret and notify appropriate colleagues and stakeholders.
- 10+ years of experience in Regulatory Affairs in a Pharmaceutical company, Biotech, Biopharma, or CRO.
- PhD, Masters Degree or Bachelor's of Science
- Demonstrated track record of successful clinical trial submissions in Canada, US, and Europe required.
- Demonstrated, handson experience, managing and preparing regulatory submissions especially Clinical Trial Applications outside of North America with a primary focus on European applications through the Clinical Trials Information System (CTIS)
- Extensive knowledge in Phase III ability to help manage all activities in Phase III
-
Account Manager
3 days ago
Facility Grid LLC Waltham, United States**Account Manager** · **Benefits** · - Unlimited earnings potential · - Direct mentorship by the company's CRO · - Comprehensive benefits package · - On-the-job training · **About Facility Grid**: · Our SaaS-based solutions include our Operational Readiness (OR) and Cx offerings. ...
-
Technical Account Manager
2 days ago
Ansys Waltham, United States**Requisition #**: 13527 · **Our Mission: Powering Innovation That Drives Human Advancement**: · When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys s ...
-
Key Account Manager
3 days ago
Leica Microsystems Waltham, United StatesFor over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we're driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus ...
-
Accounts Receivable Manager
1 week ago
Imprivata Waltham, United StatesCome join a winning team Here at Imprivata, you'll see a dedicated group of professionals who care about improving healthcare. Our team thrives on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our virtual team-building events. · While we're d ...
-
Account Manager
2 days ago
BRUCE CROHN Needham, United States**PRIMARY RESPONSIBILITIES**: · - Handle client renewals including marketing spreadsheets, plan changes and administrative issues · - Serve as liaison between client and insurance companies to resolve any service issues · - Create proposals for both new business and renewals · - ...
-
Account Manager
1 week ago
PharMerica Cambridge, United StatesOur Company: · PharMerica · Overview: · **Responsibilities**: · - Deploys advanced, consultative, and strategic approach to account management. This includes the successful implementation and promotion of various corporate initiatives · - Engages with the C-Suite, Regional or Fac ...
-
Account Manager, Global Accounts
1 week ago
Foundry Needham, United StatesOverview: · Foundry is seeking a _Global Account Manager_ to join the team This role will act as liaison and have account oversight for all aspects of designated accounts at Foundry. The Global Account Manager will provide streamlined communications to clients and internal stakeh ...
-
Account Manager/customer Success Manager
3 days ago
FoodTec Solutions Needham Heights, United States**Account Manager/Customer Success Manager (Needham, MA) Compensation: BOE Full Time** · **Responsibilities** · - Serve as the lead point of contact for all customer account management matters · - Build and maintain strong, long-lasting client relationships · - Negotiate contract ...
-
Account Manager
1 week ago
SALESBOAT INC Woburn, United StatesHeadquartered in the Boston market Salesboat is in the entire Boston area and is the largest energy consulting firm in the county providing gas and energy services specifically to the residential industry in a commercial setting. · We're seeking a top-notch account manager for th ...
-
Junior Account Manager
1 week ago
MMG Solutions Brookline, United StatesThe telecommunications industry is booming, and so are we MMG Solutions is in search for highly motivated individuals to join our expanding team. MMG Solutions is one of the fastest-growing telecommunications companies across the country. We are looking for resilient and ambitiou ...
-
Accounts Receivable Manager
1 week ago
Sancta Maria Nursing Facility Cambridge, United States**A/R MANAGER** · Sancta Maria Nursing Facility is seeking a full-time Accounts Receivable Manager to assist the Finance Director with the day-to-day operation of our business office. · - **Duties include**:_ · Directs processing of accounts receivable, adjustments/refunds, priva ...
-
Account Manager
12 hours ago
AeroShield Materials, Inc. Boston, United States**_Why AeroShield might be great for you_** · AeroShield is a collaborative team of 17 people united by the mission to deliver innovative new materials to make our lives more sustainable. Up to 40% of building heating and cooling energy is lost through windows and AeroShield enab ...
-
Account Manager
4 days ago
Dumak Boston, United States**Who is Dumak?** · Incorporated in 2004, Dumak has rapidly become a leading distributor of industrial packaging, safety and equipment supplies across Canada and in the United States. Dumak is your direct source for all your packaging needs. From small businesses to multinational ...
-
Personal Lines Account Manager
3 days ago
Cadila Global solution Needham, United States**Personal Lines Account Manager in Needham, MA** · **Responsibilities Key Accountabilities**: · - Servicing all aspects of our clients personal insurance needs, usually in partnership with an Account Executive or Producer, from renewal preparation and marketing to policy adminis ...
-
National Account Manager, Amazon
4 days ago
Candlewick Press Somerville, United StatesReports To:_ Director of Retail Sales · **_ Summary:_** · Candlewick Press, a leading publisher of books for children, is seeking a National Account Manager to sell our Candlewick, Holiday House and Peachtree lists to Amazon. Reporting to the Director of Retail Sales with the man ...
-
Clinical Account Manager
1 week ago
INSIGHTEC Boston, United States**Location**: Northeast Region (Field) · The Clinical Account Manager goal is to help drive commercial utilization at new and existing Insightec neurosurgical customers. The purpose of this role is to increase the number of patients treated to reach business profitability through ...
-
Account Manager, QA
1 week ago
Qt Group Boston, United States**About the Job**: · Qt Group is looking for an **_Account Manager, QA_** to join our sales team. As an Account Manager, you will be responsible for finding and developing new business opportunities and growing the Qt Quality Assurance customer base within a defined territory. · ...
-
Account Manager
1 week ago
Velocity Enterprises Boston Heights, United StatesYou have successfully completed your studies and have an interest in sales? Then you've come to the right place with us. · Scholt Energy is active as an energy supplier in the business customer market in Belgium, Germany, Austria and the Netherlands. · Our headquarters are locate ...
-
Assistant Account Manager
2 days ago
BIG FISH PUBLIC RELATIONS Boston, United StatesBIG FISH PR is a boutique agency based in Boston that provides public relations and corporate communications services to disruptive brands and companies. We help our clients redefine industries through thoughtful storytelling and strategic campaigns. Our clients range from major ...
-
Regional Account Manager
2 days ago
Fortinet Boston, United States**Responsibilities** · - Meet or exceed all assigned quotas and targets while forecasting weekly, monthly and quarterly revenues for the assigned account set and overall territory · - Meet or exceed the required number of face-to-face meetings each month with customers and partne ...
Account Manager - Waltham, United States - People With Chemistry
Description
Meet is working with a dynamic and innovative biopharmaceutical company dedicated to advancing Neuroscience therapies through cutting-edge research and development.
They have a focus on improving patient outcomes, and are at the forefront of clinical trials that push the boundaries of medical science.
They are actively hiring a Senior Manager/Associate Director, Regulatory Affairs to act as the regulatory lead on multidisciplinary projects and clinical study teams, to provide input on documentation and procedural requirements defined by regulatory authorities.
You will also be responsible for the following;
Qualifications: