High Priority Position: Regulatory Affairs Strategy Contractor with Oncology Exp. || REMOTE
Babu S
Dear Professional,
Hope you are doing great today...
This is BABU, BDM FROM PANTAR SOLUTIONS INC, we are an Information Technology and Business Consulting firm specializing in Project-based Solutions and Professional Staffing Services. Please have a look at below position which is with our Client and let me know your interest ASAP. I would really appreciate if you could send me your MOST RECENT UPDATED RESUME:
Role: Regulatory Affairs Strategy Contractor with Oncology Exp.
Location: Cambridge, MA (REMOTE)
Duration: 3 Months Contract .
Lead the preparation of regulatory submissions to assure full compliance with
all relevant requirements in the U.S. as well as in Europe, Canada, Japan and
Australia.
Provide strategic and operational input, guidance and oversight to global project
teams to assure that regulatory submissions and all aspects of regulatory
compliance support R&D objectives.
Develop and create regulatory compliance strategies for multiple clinical
development projects.
Coordinate all aspects of the preparation, review and submission of regulatory
documents. This includes the clinical and non-clinical portions of documents.
Represent the Regulatory Affairs Department as a member of cross functional
project teams and provide guidance relating to changing global regulatory
requirements.
Serve as the Company's Regulatory Affairs Lead in interactions with global
health authorities including the FDA, EMA, MHRA, Health Canada and ROW with
respect to clinical submission documents.
Provide leadership and direction in the development of clinical regulatory
documents including INDs, CTAs, BLAs, DMFs, NDAs and MAAs.
Make submissions to global regulatory authorities, as required, and maintain an
ongoing interactive relationship regarding these submissions.
Coordinate and maintain reporting schedules for regulatory applications.
Assure that all aspects of the Company's regulatory activities are conducted in
full compliance with applicable regulations and at the highest level of ethical
standards.
Create and maintain Regulatory Strategic Development plans and provide
strategic input in global product development planning.
Identify and communicate to executive management information about potential
regulatory issues; propose risk evaluations and mitigation strategies.
Mentor and help develop the strategic & technical expertise of regulatory
colleagues who are involved in supporting filings.
Perform other duties as assigned.
Skills:
Understanding of global regulatory submissions including compliance with FDA,
EMA, ICH and ROW clinical and preclinical regulatory requirements.
Relevant filing experience (INDs and NDAs) in leading negotiations and Health
Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC).
Experience with regulatory filings in oncology is preferred.
Strong written and oral communication skills and the ability to interact
effectively with project teams.
Ability to manage regulatory affairs activities and provide leadership in a
“hands-on fashion” while utilizing a strategic approach in
all aspects of global compliance.
Keywords:
Education:
Bachelor's degree in a
relevant scientific discipline. Master's or an advanced degree (PhD, PharmD) is
preferred.
10-15 years of regulatory affairs experience in the pharmaceutical industry.
Skills and Experience:
Required Skills:
CLINICAL REGULATORY
FDA
FILING
FILINGS
ICH
Additional
Skills:
ONCOLOGY
PRECLINICAL
REGULATORY AFFAIRS
REGULATORY COMPLIANCE
REGULATORY DOCUMENTS
MENTOR
MITIGATION
PHARMD
PRODUCT DEVELOPMENT
Languages:
English
Read
Write
Speak
PLEASE NOTE:
If for any reason this does not interest you or you felt uncomfortable by any part of this email, I sincerely apologize. Please consider this E-mail as a request for referrals and feel free in forward this email to anyone whom you might find a fit.