Manager Regulatory Affairs - Remote / Telecommute
Company: CYNET SYSTEMS
Location: Jersey City
Posted on: September 16, 2023
Job Description:
Job Description:
Pay Range: $57hr - $60hr
Responsibilities:
- Well-versed in performing CMC compliance activities including
Gap Analysis, CMC comparison, and validation for quality
reports.
- Experienced in authoring assessment reports and Part2/ Expert
reports for Dossiers.
- Experience in reviewing quality documents such as Reformulation
studies, process validations, particle size method implementation
and specification, stability indicating methods implementation,
impurity
- Serve as the CMC Product Lead for assigned products and be
accountable for the delivery of all regulatory milestones for
assigned products through the product lifecycle as needed for
product in-license/due diligence review, product divestment and
product withdrawal.
- Lead development and execution of global product and project
regulatory strategy(ies) by ensuring robust assessment of CMC
changes, identification of global regulatory requirements, and
critical evaluation of supporting documentation to confirm
acceptability and identification of potential risks.
- Planning the project by understanding the client's needs,
managing project deliverables, and providing solutions in real
time.
- Collaborate with client and external partners to support
compliant execution of change management and conduct all activities
with an unwavering focus on regulatory conformance.
- Manage execution/authoring of CMC documentation (Module 1 , 2,
and 3) for life cycle management - post-approval supplements,
annual reports, registration renewals and responses to health
authority questions per established business processes and
systems.
- Knowledge of regulatory guidelines and relevant
applications.
- Demonstrate an understanding of regulatory affairs and apply
this understanding to the benefit of the company to ensure approval
and Product supply continuity.
- Deliver all regulatory milestones for assigned products across
the product lifecycle, Deliver on agreed SLAs with clients at
contract and account/ project level.
- Meet all monthly reporting/business metrics/KPIs requirements
and manage internal control processes.
- Identify, communicate, and escalate potential regulatory
issues/risks and propose mitigation.
- Ensure established policies and procedures of the
organization/client are followed and ensure compliance.
- Demonstrate oral and written communication skills and the
ability to communicate issues in a succinct and logical
manner.
- Demonstrate ability to generate innovative solutions to
problems and effectively collaborate with and communicate to key
stakeholders.
- Demonstrate flexibility in responding to changing priorities,
multi-tasking and dealing with client expectations.
- Demonstrate effective leadership, communication, interpersonal
skills, and soft skills.
Qualifications:
- Bachelor's or masters degree required in science, engineering
or related field (advanced degree preferred).
- Bachelor's or masters degree required in science, engineering
or related field (advanced degree preferred).
- Proven and relevant regulatory affairs experience in
pharmaceutical, vaccine, or biological products; or related
fields.
- Marketing authorization experience.
- Proven Project Management experience.
Keywords: CYNET SYSTEMS, Jersey City , Manager Regulatory Affairs - Remote / Telecommute, Executive , Jersey City, New Jersey
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