Regulatory Affairs Principal
|Job Title:||Regulatory Affairs Principal|
|Location:||San Francisco, California|
|Contact Name:||Ben Richardson|
|Job Published:||January 12, 2017 12:49|
In this role you will be responsible for providing regulatory leadership for drug/device combination products from development through global market approval and commercialization. Responsible for working closely with the Manager, Regulatory Affairs to develop regulatory strategies for US and international submissions and for the planning, coordination, and authoring of regulatory submissions.
MAJOR DUTIES AND RESPONSIBILITIES:
- Provide regulatory representation and leadership to cross-functional product development teams and commercial project teams.
- Proactively develop regulatory strategies to support Intersect ENTs clinical and non-clinical development programs, marketing applications and post-marketing activities.
- Responsible for project timelines and management of regulatory submissions including authoring and preparing pre-submissions, IDE, PMA, Design Dossier and international submissions (including Japan and China) in compliance with the FDA and international regulations and guidelines.
- Responsible for the maintenance of approved applications (IDE, PMA, Design Dossier, etc.) including authoring annual reports, amendments and supplements and substantial changes, etc., as needed.
- Responsible for authoring post market submissions (30-day notices, 180 day supplements, change notices etc.)
- Establish, track and manage regulatory project timelines, status and documents.
- Provide regulatory assessments for post-approval design, manufacturing and labeling changes.
- Represent RA functional area in the review and approval of Engineering Change Orders (ECO).
- Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials.
- Provide regulatory assistance and review in clinical operations activities, including review of essential documents, adverse event reporting, etc.
- Perform regulatory research and stay abreast of new/emerging regulations and communicates relevant changes to RA management and project teams.
- Provide regulatory support for regulatory compliance activities as required.
- Maintain well-organized, auditable regulatory files.
- Other duties as needed
EDUCATION / REQUIREMENTS:
Minimum of Bachelor's degree in life sciences, engineering, or equivalent required. Advanced degree preferred. RAC certification preferred.
QUALIFICATIONS and EXPERIENCE REQUIREMENTS:
- A minimum of 8 years related experience in regulatory affairs with class III submission experience.
- Advance knowledge of domestic (US) and international (EU, China, Japan etc.) medical device and combination product regulations.
- Experience with combination products preferred
- Experience with international submissions preferred.
- Experience interacting directly with FDA, EU, Health Canada and other international regulatory agencies like PMDA, CFDA and TGA preferred.
- Demonstrated ability to work effectively in a team based environment.
- Must be detail-oriented with well-developed organizational and analytical skills.
- Demonstrated excellent written, oral, communication, presentation, planning and interpersonal skills.
- Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat.
- Must enjoy working in a fast-paced dynamic environment with proven ability to be flexible and adaptable.
- Experience in developing and submitting successful regulatory submissions with a thorough understanding of FDA regulations and ICH guidelines.
Get similar jobs like these by email
By submitting your details you agree to our T&C's
Manager Regulatory Affairs CMC (m/w/d)
Frankfurt am Main, Hessen
€65000 - €75000 per annum + negotiable
Regulatory Affairs Manager - Neuzulassung (m/w/d)
€60000 - €70000 per annum + negotiable
Director Regulatory Affairs CMC - Biologics (m/w/d)
€100000 - €120000 per annum + bonus + car
Senior Strategist Clinical Regulatory Affairs (f/m/d)
€90000 - €100000 per annum + + negotiable
Head of Regulatory Affairs (m/w/d) - München