|
|
|
|
|
 | Location  | City | Job Type | Job Title | Category | Status |  |
|---|
| MA | Cambridge | Temporary | Regulatory Affairs Staff | Scientific | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Associate Director, Regulatory Therapeutics
Position Responsibilities
- Direct management of assigned oncology programs;
- driving all submission activities (IND/CTA, trial maintenance, NDA/BLA) and health authority interactions (meeting requests and briefing documents);
- represent Regulatory Affairs at various project team and working group meetings;
- assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines;
- contribute significantly to the development of regulatory strategy plans;
- liaise with partnering companies to ensure regulatory alliance;
- act as direct point of contact with FDA and other regulatory authorities for general issues;
- mentor and coach junior regulatory staff and other team members.
Position Requirements - A BS degree in a scientific or technical discipline plus a minimum of 6-8 years experience in Regulatory Affairs is required.
- Previous experience in leading submission teams for marketing application and/or clinical trial applications is also required.
- Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements.
- Direct experience in interacting with regulatory authorities;
- Candidates must be able to influence others and demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).
Preferred Qualifications - Knowledge of EU, Canada, ROW and post-marketing and experience interacting with DDMAC is a plus.
- Advanced degree preferred.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | |
| | | We currently do not have any other open positions that match your criteria, but new positions could become available at any time. Below is a sampling of the type of positions that we have had available in the past that match your search criteria. | | |
| | | CA | South San Francisco | Temporary | Regulatory Affairs Staff | Scientific | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
Position Description
- Publishing of Regulatory Documents according to Regulatory Guidelines
Position Responsibilities - Manages contracts for more complex or larger-scale customer accounts
- Works closely with partners in field Account Management across MCCO Channel and Payer teams, reviewing customer contract needs, requirements, etc. in alignment with contracting strategies, business objectives, and other contract conditions
- Conducts various analyses and modeling of appropriate contract terms and reviews with key internal partners/stakeholders
- Obtains all appropriate and required internal reviews and approvals for contract terms and provisions
- As needed, supports field Account Management partners in negotiating contract terms and conditions
- Responds to various partner/stakeholder questions, inquiries, requests for clarification, etc. regarding contracts and terms/conditions or other items
- Ensures execution of approved and finalized customer contracts; including timely and accurate hand-off to other internal partners/stakeholders
- Monitors existing customer contracts using approved performance methodologies, tools, etc.; includes identifying and recommending opportunities for improvement
- Helps garner maximum return on investment and customer satisfaction from all contract responsibilities
- Ensures all contract data and information is appropriately entered into relevant systems/databases
Position Requirements - Bachelors Degree,
- Highly skilled in Microsoft Word and Acrobat;
- Excellent team player;
- Ability to work without supervision;
- Ability to perform under pressure.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | IL | Lisle | Temporary | Regulatory Affairs Staff | Scientific | Filled | | | Regulatory Specialist Provide nutrition and ingredient labeling expertise in compliance with local regulations. Provide technical guidance in the area of nutrient/health claims, product labeling and product positioning Develop product nutrition and ingredient information for product labels that are in compliance with government regulations. Verify accuracy of product label ingredient declarations and nutrition facts panels prior to printing or delivery to on-line printing systems. Support the development of and maintain accurate and updated ingredient and formula nutrition databases. Provide accurate nutrition information in response to customer's and consumer's technical inquiries. Provide technical support in the development of accurate nutrition/health-related communications. Develop and maintain programs to ensure products comply with internal and external guidelines and regulations. Develop and document SOP's for nutrition group processes. Influence Product Development, Marketing, Legal, and other affected functional groups using effective presentation skills to ensure product compliance with governmental regulations and work to resolve differences. Position Requirements: BS/BA (or equivalent) in Food Science, Nutrition or related field 5+ years in nutrition or related field, with a minimum of 3 years experience in Nutrition. Registered Dietician and/or M.Sc. is desirable. Must have the food composition and regulatory knowledge and expertise to recognize when the ingredient information is incomplete or inaccurate and follow up when necessary. |
| | | IL | Chicago | Temporary | Regulatory Affairs Staff | Scientific | Filled | | | Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Works with the Registration, Sales, R&D, Marketing, QA and Product Development departments to ensure that the information that needs to transfer to regulatory service, is transferred appropriately.
Position Responsibilities
- Responds to requests for information regarding registration process, customer/country lists, product listings/IDEC's, current labels/packaging.
- Derives information from Word, Excel, databases, the ERP system or Reports to compile and complete regulatory information requests.
Position Requirements - Strong detail orientation and strong proficiency with spreadsheets (excel) and systems/databases; strong verbal and written communication skills.
- Prior regulatory experience- knowledge of cGMP guidelines necessary, beauty industry experience strongly preferred.
|
| | | NC | Research Triangle Park | Temporary | Regulatory Affairs Staff | Scientific | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Responsibilities
- • Manage receipt of promotional samples and ensure accurate and timely submission of form FDA 2253 to meet company and FDA requirements
• Perform final quality control analysis on all promotional projects prior to FDA 2253 filing
• Authorize 'release for use'for all jobs requiring FDA 2253 filing--with suppliers, agencies, and internal staff
• Maintain and analyze reconciliation reports for promotional compliance purposes
• Provide advice and direction regarding final sample and FDA submission requirements to Promotion Management, Puerto Rico, US Pharma brand/business segment(s), agencies, and vendors
• Other duties as assigned
Position Requirements - -Bachelor's degree or equivalent
-Minimum of 1 year's traffic management experience in pharmaceutical or other promotion, interacting with creative, project management, and production personnel
-Excellent attention to details skills
-Excellent problem-solving skills
-Excellent planning and organizational skills
-Team player
-Excellent oral and written communication skills
-Ability to adapt to changing circumstances
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | NC | Research Triangle Park | Temporary | Regulatory Affairs Staff | Scientific | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Assisting with the preparation of high quality,detailed regulatory documents using varied information sources.
Position Responsibilities
- Edit technical documentation using supporting data processing technology.
- Conduct reviews of writing for understanding and logic.
- Working to agreed deadlines and maintaining records reflecting project status.
- Liaising closely with other company personnel to ensure accuracy of such records.
- Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
Position Requirements - Previous technical writing and /or Environmental, Health & Safety (EHS) experience
- Minimum of a Bachelor Degree required
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | NC | Research Triangle Park | Temporary | Regulatory Affairs Staff | Scientific | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Regulatory Submissions Assistant
Position Description
- Personnel will be utilized to perform services associated with the integration of Post-Approval CMC regulatory support.
Position Responsibilities
- Personnel will be utilized to perform services associated with the integration of Post-Approval CMC regulatory support for the company's North American product portfolio into. Specifically, the contingent worker will be utilized to perform activities such as developing Conformance Guides and CPIDs for the product line, as well as assist experienced Regulatory Executives in conducting the research to respond to Change Control requests from manufacturing sites.
Position Requirements - 3-5 years of Regulatory/CMC support experience.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| |
|
|
|