oce- sr regulatory affairs associate in bengaluru / bangalore

posted
contact
randstad india
position type
permanent
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posted
location
bengaluru / bangalore
function
Pharma, healthcare & lifesciences
position type
permanent
experience
9
reference number
64796
contact
randstad india

job description

oce- sr regulatory affairs associate in bengaluru / bangalore

Job Description:  Support the compiling, submission and approval of NDA and LCM licences
- Review the list of documents required for tender or any other submission (e.g. NDA, variation) and provide
on time product information as required.
- Manage the compilation and preparation of regulatory documents, information, data technical files to
support approvals for new product registration, renewals and changes (NDA and LCM licenses):
o Review the content of submission package provided by HQ according to local HA requirements.
o Identify any necessary documentation for the submission to local HA and prepare the application
form, as required, according to HA requirements.
o Support approval and post-approval activities and ensure system update with approval information
within agreed timeline.
o Compilation & delivery of Country Specific Files across IO for Renewals and Additional
Manufacturing sites
o Prepare submission operational plan and check list of local requirements for each submission
o Circulate the plans and requirements to RA in Affiliate for confirmation.
o TOC compilation according to compliance form or according to Site Transfer TOCs provided by RA
CMC & Devices: search for documents in Vault RIM and populate TOC
o Index TOC and Additional Documents received from GRA in Vault RIM
o Request additional documents and samples according to local requirements through ADocS
o Support in internal TOC QC across team
o Raise Publishing Online Form request according to submission size and publishing lead-times
o QC of Published Output
o Inclusion of original documents/certificates into the submission package
o Coordination for dispatch via EPSPUB/courier to Affiliate
o Coordination of samples if required
o Trouble shooting & subject matter expert across the team
- Ensure that all data and information submitted to HAs as part of a regulatory submission is documented.
- Monitor applications under the different stages during HA evaluation and support getting answers to
questions from the HA's.
- Support to fulfil any post-approval commitments required by HAs.
- Update and maintain paper/electronic document archival systems.
 Support in developing labelling materials and review/approve promotional materials
o Support in developing and updating labelling material according to local legislation and SOP.
 Monitor local regulatory environment and ensure regulatory compliance
- Monitor local submission requirements and developments.
- Assist in monitoring and reporting project timelines.
- Provide information on local regulatory requirements to other departments and/or Business Areas (BAs).
- Draft routine correspondence to regulatory agencies.
- Manage regulatory archiving according to local legislation and SOP’s.
Purpose and subject of interaction with internal/external customers and key contactsOCE Job Description3 of 3
Maintain an open and fluent communication flow with different external stakeholders on Affiliate level.
Other Areas of Responsibility
• Continuous improvement/simplification of current process
• Actively involved in cross functional activities
• Responsible for sharing better practices
• Responsible for own continuous development
Quality Assurance:
• Responsible for complying to procedures and systems
• Ensuring quality of submissions Education requirements
Post-Graduation or comparable degree in Science or equivalent professional experience
Work experience
 Above 6 years of experience in Pharmaceutical Industry in Regulatory Affairs
 Experience in compilation of Registration/Re-registration dossier in National/eCTD/NeeS & Standard format
 Experience in Document Management system
Personal skills
• Knowledge in MS-Office
• Good Communication Skills
• Good subject knowledge in academics
• Detail oriented
• Active in self development
• Readiness to changes
• Service minded and customer oriented
• Demonstrates a high-quality mindset
• Ability to work in teams
• Active involvement in Business process
• Flexibility and Readiness for handling other tasks

skills

Documentation, Regulatory affairs, Stake holder management, compilation

qualification

Any