• Associate Manager II , Regulatory CMC Jobs in Hyderabad,India - 25368581

  • Novartis AG
  • Save Job
  • 4 - 7 Years
  • Posted : above 1 month

Job Description:

Job ID 283935BR

Position Title Associate Manager II, Regulatory CMC

The Associate Manager, Reg CMC will broadly be responsible for

1 Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle

2 Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle

Your responsibilities
Your responsibilities include, but are not limited to
Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines

Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible

Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends

Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned

Establish and maintain sound working relationships with partners and customers 8 Assume activities in support of the general department such as DRAGON sup-port, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database en-try activities (specialized department functions)

Minimum requirements What youll bring to the role
Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent

Fluent English required (oral and written)

Good skills in site (local) language desired (oral)

Minimum 4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals

Working knowledge of chemistry/biotechnology, analytics or phar-maceutical technology Knowledge of the drug development pro-cess desirable

Ability to critically evaluate data from a broad range of scientific disciplines

Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable

Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload

Effective planning, organizational and interpersonal skills

Reasonable approach to risk assessment
Excellent written/spoken communication and negotiation skills Computer literacy

Why consider Novartis
750 million Thats how many lives our products touch And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more peoples lives

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment Where youre given opportunities to explore the power of digital and data Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges

We are Novartis Join us and help us reimagine medicine

Division Global Drug Development

Business Unit REG AFFAIRS GDD

Location India

Site Hyderabad, AP

Company/Legal Entity Nov Hltcr Shared Services Ind

Functional Area Research & Development

Job Type Full Time

Employment Type Regular

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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