Director Regulatory Affairs job Jersey City New Jersey
Director Regulatory Affairs job Jersey City New Jersey
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Director Regulatory Affairs Job



Employer Name: SpiderID: 9866188
Location: Jersey City, New Jersey Date Posted: 10/5/2020
Wage: Category: Biotech
Job Code:
Number Of Openings: 2

Job Description:
 Lead regulatory activities (nonclinical, clinical and CMC) to assure timelines and milestones.
 Interface with Commercial Regulatory Affairs developing GRASPís.
 Interface with Business Development conducting due diligence and assessing commercial
viability of potential drugs.
 Provides Regulatory Risk Assessment (RRA) during various phases of product development.
 Monitor current and proposed regulatory and legal issues, and ensure that key initiatives are
communicated to the stakeholders.
 Coordinate all aspects of regulatory submissions relevant to assigned programs, including
coordinating regulatory workflow, reviewing technical documents (nonclinical, clinical, and
CMC), developing and tracking submission timelines, and supervising preparation of
regulatory submissions to ensure compliance with regulations and guidelines.
 Prepare IMPD to support international CTA submissions.†
 Lead as a key member of Global Regulatory Project Teams.
 Lead multidisciplinary team responding to Health Authority questions during the IND and NDA
review phases for assigned projects.
 Act as liaison between Regulatory Affairs and other functional areas, including external
contractors (e.g., contract research organization teams and vendors).
 Support Quality Assurance activities during pre-approval GCP and GMP FDA/EMEA/PMDA
inspections.
 Work with development partners as required; assist in due diligence activities.
 Expand and precede the organization's policies and procedures for regulatory affairs and
compliance to establish a compliant culture.
 Maintain knowledge and monitor changes in pertinent laws, regulations and guidance.
Interpret external developments and inform/educate internal stakeholders.†
 Identify the need for new regulatory policies, processes and SOPs, approve and ensures
implementation.


Job Requirements:
Educational Requirements

Ph.D. or Pharm. D. or equivalent experience in a scientific discipline or equivalent will be
preferred. Bachelors or Masterís Degree will be considered with relevant experience in
Regulatory Affairs. Regulatory Affairs Certification is favorable. †

Professional Work Experience
 Minimum of 8-10 years of regulatory experience respectively within the pharmaceutical or
biotechnology (preferred) industry.


Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 8
Education Required: Bachelors
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: ravalika k Company Type: Staffing Agency
Company: AnanSys Software
City: Fairfield
State: California
Zip: 94533
Web Site: https://anansys.com/

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