Life Science: Regulatory Submissions Publisher: Apply Now

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;

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

Skills Required
Regulatory Submissions, Fda, ectd