Celegence Systems Walk In Interview 2025.Celegence Systems Notification full details below..Interested and eligible candidates can attend interview on scheduled time and venue.
Vacancy details:
- Department: Regulatory Specialist in Life Sciences /Pharma
- Qualification:Degree in lifesciences / B.Pharma / M. Pharma
- Experience: 05-10 yrs
Important Details :
- Location: Bengaluru
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Job Description: Greeting from Celegence Systems !!!!!
Qualification(s)
Degree in lifesciences / B.Pharma / M. Pharma
Experience(s)
- 6 to 9 years of prior CMC writing experience preferred; Interested in expanding his/her knowledge of pharmaceutical manufacturing and testing as it pertains to eCTD Modules 2 and 3 writing and support labelling activities
- Experience in the pharmaceutical or CRO industry preferred
- Experience in pharmaceutical manufacturing or testing activities is mandatory
Technical Skills
- Good Chemistry Manufacturing & Control (CMC) writing skills and understanding of ICH requirements
- Proficiency with MS Office applications and style guides for writing various document types
- Ability to convert technical information into regulatory-compliant documentation
Soft Skills
- Excellent English written and verbal communication skills
- Good organizational, interpersonal and communication skills
Competencies
- Good knowledge of industry regulations and compliance requirements applicable to pharma/life sciences
- ICH Guidelines and eCTD knowledge
Personal Traits
- Good planner and Skilled communicator
- Well organized to work independently with minimum oversight
Roles and Responsibilities
- Analyze source documents such as PDR, BMR, MFR, Stability data and create, edit and manage the production of high-quality M2, M3 CMC sections for IND/IMPD, BLA/MAA, HAQs to support timely submissions of investigational and new marketing / renewal applications.
- Experienced in handling Biopharmaceuitcals / Gene Therapy related submissions is preferred
- Ability to independently author Plasma Master Files (PMFs) / DMFs for US/CAN/EU needs is preferred
- Works with other writers for developmental purposes and writes documents with little oversight, as applicable
- Reviews deliverables with little oversight prior to releasing to client.
- Addresses client comments during document lifecycle; manages expert/scientific reviews and revisions; performs clean reads
- Learns to independently implement and validate QC findings as per agreed procedure
- Understands ICH and other guidelines towards CMC M2 and M3 writing activities, maintaining knowledge of the current regulations and upcoming changes
- Practices good internal and external customer service with good project coordination skills to anticipate and mitigate risks
- Participates in improvements to departmental processes
- Develops internal and external leadership skills
- Adhere to processes related to project management as appropriate for regulatory submissions
- Complies with document and record control procedure
- Ensures compliance to applicable IQMS policies and procedures
Time and Venue
15th February , 9.30 AM – 5.30 PM
Elephant Rock Road, 120/A, Pattalamma Temple Rd, Jaya Nagar 1st Block, Jayanagar 3rd Block, Jayanagar, Bengaluru, Karnataka 560011 (View on map)
Contact – Mini Desai Lad ( 8050022417 )