Parexel Hiring SENIOR
REGULATORY AFFAIRS ASSOCIATE B.Pharm or M.Pharm or any Life Sciences related
discipline
RESPONSIBILITIES
Good
understanding of regulatory framework, including regional trends, for various
types of applications and procedures for small and large molecules across all
regions as well as knowledge of global pharmaceutical legislation and guidance
specifically linked to regulatory CMC aspects in the ICH countries . Experience
with ROW countries would be a plus.
Expertise
in CTD / eCTD compilation and submissions, technical review of the submission
documents as well as Post Approval activities: Renewal, Variations and other
lifecycle management activities (preferably for Europe, USA and International
markets would be an asset). Exhibit excellent CTD writing skills.
Comprehensive
knowledge and experience with developing regulatory CMC strategies and CMC
dossier content requirements
Products
Portfolio includes: Medicinal Products, Consumer Health, Biologicals, Vaccines
etc…
.Lead
and / or contribute to the planning, preparation (including authoring where
relevant) and delivery of simple, and with experience, increasingly more
complex regulatory maintenance submissions from either a global and/or regional
perspective.
Liaise
closely with cross-functional members with aligned product responsibilities.
Develop,
execute and maintain submission delivery plans, submission content plans, and
proactively provide status updates to designated stakeholders.
Identify
regulatory risks and propose mitigations to Lead RPM and cross functional
teams.
Support
operational and compliance activities for assigned CMC deliverables, including
generating work requests and submission content plans, submission tracking and
document management utilizing the support and input of Global Regulatory
Operations and Marketing Companies.
Must
able to prepare, review and submit Administrative, CMC related, Labelling as
well as Safety variations to Health Authorities and also perform post Approval
related updates (where applicable)
Ensure
that the Regulatory Information Management system is maintained and updated for
all activities under role responsibility, including review of documents
Well
versed with MA Transfers and related activities preferably for EU and
international markets.
Strong
knowledge and experience of CMC gap assessment and defining CMC action plans.
Determine
the types of regulatory submissions or internal documentation that are required
in situations.
Gap
regulatory assessment (regulatory strategy) based on relevant HA requirements.
Preparing
and Prioritizing the gap resolution dossier concerning the update of the MA
dossier as needed
Supports
Site regulatory product managers with regard Regulatory Gap assessments
Supports
Site project teams and external stakeholders as part of project execution
Must
able to handle Health Authority Queries, Change Control management as well as
the coordination and follow ups with internal / external stakeholders and local
RA affiliates.
Must
able to perform Artwork reviews
Assist
and provide support in the preparation, distribution and follow up of
registration documentation required to affiliates/ regulatory authorities
Identify
relevant guidance documents, international standards, or consensus standards
and provide interpretive assistance
Maintain
current knowledge base of existing and emerging regulations, standards, or
guidance documents
Exhibits
good project management skills.
Demonstrates
ability to prioritize work and define steps needed to achieve specified project
outcomes.
Ensure
that quality standards are met and that the deliverables meet strict deadlines
Excellent
interpersonal and intercultural communication skills, both written and verbal.
Attention
to details and ability to think strategically
Multi-tasking
ability.
B.Pharm
or M.Pharm or any Life Sciences related discipline
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