Consultant-CMC

2 weeks ago

Sany, India Randstad India Full time
Functional Responsibilities
Work with globalclients on regulatory filing projects for the US EU UK ChinaAPAC
Canada etc. The key delivery areas include Pre andPost approval CMC authoring
preparation andsubmission
Scientific writing review and compilation ofsubmission documents such as quality
overall summary(module 2) CMC quality drug product drug substance andregional
information (module 3)
Independentlyauthor and/or coordinate CMC activities for new registrationspost
approval changes (minor moderate and major)renewals annual reports and line
extensions to meetfiling requirements. Coordinating and contributing to responsesto
Agency queries and performing quality review ofregulatory CMC submissions
Deliver projects in eitherpharmaceutical / consumer products / Over the counter(OTC)
drug products as per clientportfolio/requirements
Ensure timely delivery oferrorfree highquality CMC documents that meet
international standards of written English and relevant technicalrequirements following
internal/clientspecific styleguides/templates
Demonstrate expertise at planning CMCsubmissions including appropriate knowledge
managementtools . Job Description
Participate in meetings with Client on aregular basis to understand the clients
requirement andproactively support the team in meeting or exceeding the targetsin
terms of quality and quantity within the agreedtimelines
Demonstrate indepth understanding of contentrequirements including awareness and
understanding ofCTD format and apply expertise to ensure globalregulatory
commitment tracking
Prioritize andcomplete assigned workload appropriately under minimumsupervision
Proactively identify moderately complexissues and risks to project delivery in own work
or workof the team and escalate appropriately with associated resolutionproposals
Work crossfunctionally and in collaborationwith key stakeholders/customers both
internal andexternal
Ensure that all training (internal training andclient training) are successfully completed
in a timelymanner Skills and general profile
Good understanding of global regulations USFDA EMA MHRA APAC TGAetc.
North America experience in ANDA NDA IND and basicCMC Life Cycle Management
supplements as well asCanadian filings.
EU experience in initial filing andlife cycle management (Type 1A Type 1A/1N Type 1B
andType II variations).
Knowledge of US and Canadianregulations will be required.
Strong working knowledgeof electronic document and submission standards
Excellent communication skills and effective in a collaborativeteam environment
Advanced skills in the use of MS WordAdobe Acrobat Documentum systems
Effective interpersonalskills
Strong verbal and written Englishskills
Ability to work in a fastpaced cohesivecollaborative teamoriented work
Environment
Commitment to highest quality outputs including meticulousattention to detail JobDescription Enthusiasm and proactivity
Education
M.Pharm/PhD or equivalent higher degree in a relevant discipline(preferably
Regulatory affairs Pharmaceutics QAIndustrial Pharmacy Life Sciences) WorkExperience
Minimum 610 years of regulatoryaffairs/operations experience in the relevant area
(e.g.Pharma Consumer Medical device)

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