Senior Director Regulatory Affairs: Celera
| Job ID | 09-0281 |
|---|
| Company Name | Celera |
|---|
| Job Category | Pharmaceutical/Biotech |
|---|
| Location | Alameda, CA |
|---|
| Position Type | Full-Time, Employee |
|---|
| Salary | $150,000 to $199,000 per year |
|---|
| Experience | 10-15 Years Experience |
|---|
| Desired Education Level | Bachelor of Science |
|---|
| Date Posted | October 29, 2009 (Reposted Nov 18) |
|---|
| View Celera profile and job listings |
CDRH, PMA, IDE, 510(k), CBER, FDA Submissions
Senior Director Regulatory Affairs
Location: Alameda - Harbor Bay
Employment Status: Full-time Regular
Summary:
Celera is a healthcare business that uses knowledge of human variability to provide new tests and services to personalize disease management. Our Products business develops and manufactures molecular diagnostic products. Our Services business, Berkeley HeartLab, Inc. (BHL), is a high complexity CLIA certified laboratory that offers over 25 clinical diagnostic tests. And our 4myheart centers are staffed with medical professionals who use results from testing at BHL to work with patients, under their physician’s direction, to develop customized regimens for exercise, nutrition, stress management and therapy compliance. Supporting these businesses, our internal research and partnering activities fuel the development of new diagnostic tests for personalizing disease management in our products and/or services. For more information about Celera, please visit us at www.celera.com
BASIC FUNCTION AND SCOPE OF THE POSITION:
Directs, plans and manages a department function that executes strategies to market new innovative diagnostic devices which meet governmental requirements in the US and the rest of the world. Creates submissions that are clear and concise to achieve regulatory clearance/approvals in minimal time frames. Encourages, develops, edits and reviews departmental and/or investigator publications in support of Celera products. Review and approval of clinical strategies and protocols as related to submissions. Accountable for ensuring that Celera product labeling is compliant with all domestic and international labeling regulatory requirements. Directs the activities of domestic and international submission experts both internally and externally. Provides expert advise to executive management and technical personnel regarding domestic and international submissions requirements and strategies. Takes the lead on routine interactions with the FDA and international authorities on submission matters. Liaison with marketing and sales force for appropriate advertising and promotional activities.
IMPACT:
Successful performance contributes to receipt of and maintenance of regulatory approval for Celera products. Decisions would affect the financial, employee, or public relations posture of the company. Erroneous decisions or recommendations would result in failure of the overall success of the function, division or company operations.
ESSENTIAL JOB DUTIES:
• Responsible for supervision of direct reports which includes interviewing, hiring, training, goal setting, evaluating performance, prioritization of work, salary administration, career development, and compliance with personnel, financial and safety policies. Represents the department to other groups in the company.
• Directs preparation of all required submissions to regulatory bodies, licenses and certificates to allow Celera products to be legally marketed.
• Ensures that pre-clinical development is commensurate with regulatory requirements and product claims.
• Review and approval of clinical strategies and protocols as related to submissions.
• Develops and manages high-performance teams including outside resources.
• Maintains expertise for international governmental regulatory marketing requirements such as ISO, CE, Canadian Medical Device, etc.
• Ensures appropriate Regulatory Plans for product development teams.
• Encourages investigators to publish data to support Celera products through building relationships with external research collaborators and development partners.
• Develops and maintains budgets to support regulatory submissions, licenses and other RA activities.
• Provides recommendations on product approval status and actions to be taken to achieve the objectives of the business plan.
• Manages direct reports for assigned projects and acts as backup for department head.
• Prepares regulatory Letters to File and product update reports, as necessary.
• Ensures appropriate statistical analyses are applied to data that support product claims.
• Reviews product label copy, promotional and advertising materials and manuscripts for publication.
• Manages the Regulatory Affairs staff including recommendations and justifications for staffing and training needs.
• Establishes departmental goals and objectives in support of meeting the business plans.
QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE:
B.S. degree in a scientific field with at least twelve (12) years of postgraduate industrial experience with at least seven (7) of those years in industrial diagnostic clinical trial and regulatory submission experience. Must have at t least five (5) years experience managing a Regulatory department at a Sr. Manager/Director level. FDA Advisory committee experience preferred.
LANGUAGE SKILLS:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the scientific community. Ability to write publications that conform to prescribed style and format.
MATHEMATICAL SKILLS:
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of science or engineering and algebra. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
LICENSES, CERTIFICATES, REGISTRATION:
None.
OTHER KNOWLEDGE, SKILLS AND ABILITIES:
Must possess excellent command of the English language and demonstrated proficiency in written and oral communications. Computer skills with basic workplace software such as Word and Excel are required. CDRH experience with PMA submissions and approvals, 510(k) submissions and approvals and/or IDE submissions are a requirement. CBER submissions experience is a desirable. He/she must demonstrate the creative ability to develop and apply new skills and creative approaches to a myriad of complex problems. His/her primary function is to solve problems, which are highly complex and require very knowledgeable and sophisticated regulatory, clinical, statistical, chemical, biological and business approaches for effective resolution. The Director must be able to work effectively within technical groups involving many other disciplines. A high degree of technical expertise and the demonstrated ability to apply this expertise the regulatory submissions is required. Must be able to understand the “moving bar” of FDA submissions requirements and be comfortable in interpreting FDA submission guidance documents and international standards. Must be able to assess and communicate degrees of risk as part of regulatory submissions recommendations. The Director must understand current FDA regulations, guidelines, thinking, concepts of regulatory strategies and requirements to deal with the broad problems and issues involved in regulatory submission activities. He/she must have in-depth knowledge and understanding of the chemistry, biology manufacturing processes and quality sciences relating to the products and processes.
Project management skills are essential to enable efficient planning and execution of submission time lines. Must have strong technical and analy | |
