Walk-in Drive Regulatory Specialist in Life Sciences /Pharma

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