Regulatory Submissions Publisher

Job Code # 372

Job Location-  Noida

Salary- 6 LPA to 10 LPA

Key skills-
a) Grad or PG in Nursing, Pharmacy or Life Sciences
b) 2or more years of experience in pharmaceutical industry submission
publishing or related technical skills
c) Familiarity with FDA or EU regulations & guidelines

Job Description-
Job Purpose:

Build and process submission dossiers of low-to-moderate complexity:
➢ Submission Dossiers that may be periodic (e.g.: safety reports) or minor
amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as
appropriate to level, etc) or otherwise not major applications but in support
of pending approvals or lifecycle commitments for marketed products
(e.g.: meeting packages, responses as appropriate, Advertising and
Promotion Submissions, routine labeling updates as appropriate, etc.).

➢ QC submission dossiers or parts of submission dossier output of low-to-
moderate and moderate-to-high complexities as assigned.

➢ Other submission related requests could be assigned that are in support
of general publishing but commensurate with role expectations.

Role and Responsibilities:
➢ Utilize current electronic document management and publishing tools to
prepare submission-ready Regulatory components and assemble, publish,
and dispatch dossiers according to regulatory requirements for paper and
electronic submissions with limited supervision
➢ Provide GRA component-level publishing support to ensure submission
components conform to e-submission standards (e.g., templates,
scanning, indexing)
➢ QC electronic and paper submissions to ensure compliance with company
and agency requirements.
Maintain effective interactions with all publishing contributors and
responsible RA professionals, to ensure timely delivery of dossier
components taking into consideration special requirements and needs;
➢ Maintain open and timely communication; and
➢ Determine the scope of the electronic publishing requirements for the
dossier
➢ Apply appropriate JRD document and dossier standards, including
adherence to a pre-established submission content plan
➢ Participate in special projects and process improvement initiatives.
➢ Global Regulatory knowledge of product registration procedures covering
IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including
regulated markets like US, EU, Canada and Australia-NZ.
➢ Support regulatory submissions publishing for EDMF, COS/CEP for Drug
substance related filing and regulatory submissions publishing in MRP,
DCP, CP and National filing for the EU or
➢ Support regulatory submissions publishing for Annual reports, Safety
Reports, updates to DMF, labeling, stability and CMC sections for US.
➢ Reviews and maintains regulatory database comprising existing and new
regulations pertaining to submission requirements for the region.
➢ Regular interaction with internal stakeholders and external stakeholders
like Local Affiliates/ MC (Marketing Company) through emails &
teleconference, through proper communication channels to ensure
accuracy and completeness of submission and resolving issues as and
when they arise.
➢ Escalates unresolved issues appropriately as per the agreed escalation
process.
➢ Ensures that the quality and TAT targets defined are always met.
Experience Required:
➢ Two or more years of experience in pharmaceutical industry submission
publishing or related technical skills
➢ Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is
required
➢ Experience with word processing, use/applications of templates,
bookmarking, hyper-linking, Microsoft Office applications is required
➢ Familiarity with FDA or EU regulations & guidelines is preferred
➢ Practical understanding of evolving technologies in support of business
area is preferred

Skills Required:
➢ The candidate should possess strong attention to detail, exhibit excellent
interpersonal communications (in English, both verbal & written),
organizational, time management and follow-up skills.
➢ The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments
➢ Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines
➢ Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs)
➢ Basic understanding of information management concepts and tools needed to support business area.
➢ Use various technical skills to resolve publishing/document preparation issues.
➢ Ability to demonstrate a solid command of the technical tools at the level required to perform job duties
➢ Problem solving skills
➢ Management of team
➢ Knowledge of business principles.