Regulatory Affairs Director jobs in Spokane, WA
Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Director jobs
- Jubilant Pharma Holdings Inc.
-
Spokane, WA
FULL_TIME
-
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.
Our Promise: Caring, Sharing, Growing
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.
Job Description:The Associate Director, Medical Affairs leads the team that supports direct and indirect two-way communication on medical and technical matters with the Allergy Business Unit sales representatives and their customers. To improve and foster technical relationships between the business and its customers. To grow the ABU market penetration of teaching institutions with allergy fellowship programs. This position works closely with R&D to advance science within the Allergy space.
Essential responsibilities include but are not limited to:
- Assist sales representatives with new allergy fellows (Allergists and ENT’s) office set up by providing training and advice on extract mixing and formulation of patient specific treatment sets and related subjects. Partner with sales representatives to explain differentiated products.
- Act as a SME for non-routine medical and technical questions from sales representatives and customers related to allergy diagnosis and immunotherapy treatment. Partner with commercial leaders to ensure that science being communicated by field-based teams is accurately represented and relevant to the practicing physician community.
- Create white papers as requested by Sales & Marketing on subjects that relate to the safety and efficacy of JHS products suitable for distribution to customers.
- Prepare and present to JHS customers, presentations on subjects of mutual interest to the allergy profession and JHS management. To include but not limited to in-office, journal clubs, regional or national meetings. Lead and support pollen walks across the country.
- Partner with Key Opinion Leaders to understand trends within the Allergy space and how JHS can further the science to support customers.
- Establish and maintain advantageous contacts in government, academia and industry, including potential grant applications.
- Represent the company at scientific conferences and forums, presenting research findings and enhancing the organization’s scientific reputation.
- Participate in sales training and provide suggestions for improvement.
- Oversee the Medical Science Liaisons
Qualifications:
- Bachelors of Arts or Science; Major(s): Scientific discipline or healthcare preferred. Master’s Degree or Doctorate Degree desired.
- Minimum 5 years with a M.S. or Doctorate Degree
- Minimum 10 years with a B.S. Degree
- Minimum 10 years FDA regulated industry experience, i.e. a pharmaceutical, medical or healthcare industry
- Allergy and/or Immunology experience desired
- R & D experience desired
- Microsoft suite
- Solid understanding and working knowledge of US Pharmaceutical and/or Medical Device laws, regulations, standards, policies and guidance documents
- 25-40% travel availability
Compensation:
This position pays $102,120 to $170,144 per year, depending on experience, with opportunity for growth, promotion and annual raises.
Benefits:- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
- Life, AD&D, Short and Long Term Disability
- 401(k) with company match
- Generous paid time off plan Employee Assistance Program
Optional Benefits:
- Voluntary Life and AD&D for employee & family
- Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
- Pet Insurance
- ID Theft Protection
- Perk Spot Discount Program
Jubilant HollisterStier is an EEO/AA Employer.
All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability.
If you require assistance applying for a position, please contact our HR Department at:
HResources@jhs.jubl.com
Job OverviewDATE POSTED :
27/03/24
LOCATION :
Spokane, Washington
COMPANY :
Jubilant HollisterStier Spokane
FUNCTION :
Regulatory Affairs - 20 Days Ago
- Interior, Bureau of Indian Affairs
-
Nespelem, WA
FULL_TIME
- This position is located with the Bureau of Indian Affairs, Northwest Region, Colville Agency, Deputy Superintendent-Trust Services, Branch of Forestry in Nespelem, Washington. NOTE: TRAVEL AND RELOCA...
- 12 Days Ago
- US Interior, Bureau of Indian Affairs
-
Wellpinit, WA
FULL_TIME
- Duties Duties listed are at the full performance level at the GS-08. If selected at the lower level, you will have the opportunity to learn to perform these duties and receive training to develop in t...
- 7 Days Ago
- Washington State Department of Veterans Affairs
-
Spokane, WA
FULL_TIME
- We are excited to announce with have 1 opening for a Registered Nurse 2, Full-Time Permanent, on our Day Shift, here at the wonderful Spokane Veterans Home!Expected work hours will be 6:00 am to 2:30 ...
- 22 Days Ago
- HF Sinclair Corporation
-
Spokane, WA
FULL_TIME
- Basic FunctionHF Sinclair Midstream is seeking a Regulatory Compliance Specialist. This position is open to location. The Regulatory Compliance Specialist conducts and supports compliance of DOT/PHMSA...
- 1 Month Ago
- University of Idaho
-
Moscow, ID
FULL_TIME
- University of Idaho Director of Marketing Location: Moscow Division/College: University Communications & Marketing Employee Category: Exempt Pay Range: $72,000 annually or higher commensurate with exp...
- 13 Days Ago
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0 Regulatory Affairs Director jobs found in Spokane, WA area
- Volex
-
Spokane, WA
- Job Summary & Essential Functions: The following describes in general terms the purpose and scope of the position. The P...
- 4/21/2024 12:00:00 AM
- Frontier Behavioral Health
-
Spokane, WA
- Frontier Behavioral Health's presence in Spokane is more than 100 years strong, allowing our non-profit organization to ...
- 4/21/2024 12:00:00 AM
- Kootenai Health
-
Coeur D Alene, ID
- Executive Director, Surgical and Perioperative Services 28173 Position Summary: Provides operational, tactical, and stra...
- 4/21/2024 12:00:00 AM
- Curo Health Services
-
Liberty Lake, WA
- Our Company Gentiva Hospice is a member of the Gentiva family - an industry leader in hospice, palliative, home health, ...
- 4/19/2024 12:00:00 AM
- Travelers Insurance Company
-
Spokane, WA
- Who Are We? Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this...
- 4/19/2024 12:00:00 AM
- Volex
-
Spokane Valley, WA
- Job Summary & Essential Functions: The following describes in general terms the purpose and scope of the position. The P...
- 4/18/2024 12:00:00 AM
About Spokane, Washington
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