Sr. Exe - Regulatory Affair
KEY FUNCTIONS / RESPONSIBILITIES
Review and submit the Abbreviated New Drug Applications (ANDA) for US market and submit the Marketing Authorization Applications (MAA) for EU region.
Initiate the submission of all the dossiers in eCTD format across US and EU.
Initiate the submission of eLabeling i.e., SPL and PLR for US market.
Review and submit responses for the queries received from the USFDA and EU regulatory agencies.
Review and submit the supplements & variations for filing the post approval changes in the US and EU region.
Review the analytical document of raw material and finished products specifications & test procedures, packaging material specifications & test procedures, in-process specifications & test procedures, analytical method validation protocols and reports etc.
Review the development documents like master formula records, product development reports and stability protocols etc.
Review the plant documents like batch manufacturing records, process validation protocols and process validation reports etc.
Ensure the compliance of the registration dossier in line with the practice at plant.
Update the team members by providing various presentations on regulatory topics.
KEY RESULT AREA
o Review and submission of ANDA
o Review and submission of responses to the queries
o Review of all documents related AD, PD, QA, MA & Plant
Mandate Skills required:
Person should have worked for eCTD filing for injectable and ophthalmic.
C date should be able to join within a month.
Should be a male candidate.
Should be a North Indian
Should have worked in good pharma companies.
Established in the year 1993, New Era has been in the business of understanding talent needs... of different organizations and providing solutions for it. New Era hires consultants with specialization in different domains to provide procurement solutions across all the domains. We have been very fortunate to serve some of the top names of both the IT and the non IT Industry. We provide end to end staffing solutions and help candidates to be placed across Asia, USA and Europe.
New Era also provides Training and Development solutions to our clients which help enriching the performance of their Human Capital. Our training and development initiative ‘TRUTH’ offers complete and measurable ‘Aptitude Development Solutions’ in areas like Leadership Development, Time Management, Corporate Communications, Presentation Skills, Consultative Selling Skills, Marketing Skills etc.
New Era values its Human Capital the most and is totally committed towards providing them with adequate training and development programmes at a regular basis. This helps their grooming and also equips them with the knowledge of the latest Industry practices. We at New Era always follow the 3‘i’s which we believe are the pillars of our success. Read full description
- Last updated:
- Job type:
- Full time
- Position type:
- Minimum experience:
- Between three and five years
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