Director Regulatory Affairs
Company: Robsco Search
Location: Newark
Posted on: January 12, 2021
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Job Description:
The Director of Regulatory Affairs provides strategic global
regulatory guidance to cross-functional project teams responsible
for product development. The successful candidate has a proven
track record in the development of drugs, biologics/vaccines, and
also in the rare disease space. In this role, the Director defines
and implements regulatory strategies; works with cross-functional
project teams to execute the agreed-upon strategies; supports
departmental activities with regards to clinical trial conduct and
regulatory submissions. MAJOR ACTIVITIES AND RESPONSIBILITIES
Reporting to the Senior Director of Regulatory Affairs and CMC, the
Director will: Actively lead development and implementation of
regulatory strategies for assigned programs and ensure cross
functional alignment. Lead regulatory activities (CMC, nonclinical,
and clinical) to assure timelines and milestones. Interface with
Commercial Regulatory Affairs developing GRASPs. With support of
Commercial RA, develop initial product labeling and assess proposed
product claim proposal (pre-NDA). 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 (clinical and nonclinical, CMC), developing and tracking
submission timelines, and supervising preparation of regulatory
submissions to ensure compliance with regulations and guidelines.
It is expected that the Director will also have some experience
outside the US. Review and approve protocols, reports, and
documents used in regulatory submissions. 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. Works closely with Regulatory
Operations to ensure e-CTD compliance. QUALIFICATIONS AND
BACKGROUND REQUIREMENTS Educational Requirements Ph.D. or Pharm. D.
or equivalent experience in a scientific discipline or equivalent
will be preferred. Bachelors or Masters 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. Experience
with designing and executing creative development strategies for
NCE and biologics development programs. Detail-oriented with the
ability to detect and correct errors and/or inconsistencies in a
variety of documents. Comprehensive understanding of FDA
regulations and ICH guidances, as well as comprehensive experience
in the drug development process. Experience preparing and
overseeing regulatory submissions, including INDs/Clinical Trial
Applications and Marketing Applications in electronic Common
Technical Document format. Experience with international clinical
trials and regulatory documentation. Excellent communication
(written and verbal) and collaboration skills. Expertise in
translating regulatory requirements into practical, workable plans.
Experience in preparation of critical submission documentation, and
communications with FDA and other regulatory agencies. Ability to
build effective relationships within a team/collaborative
environment, with a high level of professionalism. Proven track
records working with regulatory agencies. Able to travel as
required within a global work environment.
Keywords: Robsco Search, Newark , Director Regulatory Affairs, Executive , Newark, New Jersey
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