bengaluru karnataka regulatory affairs manager Jobs – 38 Open Jobs Today

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Project Manager Validation Services

Sartorius -
Bengaluru, Karnataka

Apply Now

Job details

Full-time
1 day ago

Qualifications

English
Project management
Manufacturing

Full job description

For Sartorius Stedim India Pvt. Ltd, we are looking for Project Manager Validation Services to join our team in Bangalore. In this role, you will be responsible to manage Pharma and Bioprocess Validation Projects (including e.g. filters, bags, other single-use components) for the local market based on customer and regulatory requirements while ensuring close involvement of customers and internal stakeholders.

What you will accomplish together with us:

Management of Validation Projects

Understand customer requirements and concerns.
Coordination of validation projects on behalf of customers in a timely manner according to the agreed test scenario as well as in compliance with regulatory requirements (e.g. FDA, EMA, WHO).
Provide technical consultancy and risk assessment based on Sartorius Stedim validation philosophy and globally harmonized test methods.
Preparation of quotes for different test scenarios / scopes.
Ensure efficient and effective completion of validation projects under consideration of complexity and time in coordination with the sales team, the customer and the validation lab(s).
Preparation, review and approval of scientific and technical validation documents (statements, protocols, reports and other documents) in English.
Track all validation leads and projects via applicable tools and provide monthly summary report.

Support of sales of Validation Services

Promotion of validation services to customers and local markets (workshops, webinars, etc.)
Support the consumables business growth via cooperation with application specialists for cross selling.
Customer visits, travel and training (e.g. acquiring new projects, presentation of Validation Services, generating validation leads).

Regulatory Affairs Support

Support preparation of regulatory workshops by providing summaries of relevant regulations and provide customer support on the regulatory requirement or updates.
Articulate to customers and in projects the regulatory framework as relevant to both the customer’s milestones as well as the respective Sartorius technologies. Formulate and execute action plan of how Sartorius technologies and services can help achieve the customer’s or the project’s regulatory goals.
Perform Regulatory surveillance on topics covered by the validation services such as leachables/extractables, validation of single-use systems, analytical methods, acceptance limits.

What will convince us:

Minimum 5-10 years experience in Validation Services, Filtration or life science industry.
Previous and proven experience supporting single-use bioprocess validation projects either hands-on or in advisory capacity preferred.
Knowledge on the concept of Extractables / Leachables and related analytical methods, e.g. HPLC-UV, GC-MS, LC-MS
Good understanding of drug manufacturing processes and pharmaceutical industry regulatory requirements ( FDA, EMA, WHO etc.)
Familiar with concept of GMP and GDP (Good Documentation Practices)
Experienced with Project Management and Teamwork in global environment
Familiar with concept of GMP preferred.

Apply Now

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regulatory affairs manager jobs in bengaluru karnataka

Project Manager Validation Services

Legal Manager

Senior Clinical Data Manager

Senior Manager of R&D PLM

Clinical Marketing Manager

Senior Group Manager - Product Marketing

Webinar Expert

Global Classification Senior Specialist

Medical Writer

Assistant Marketing Manager

Principal Corporate Counsel- Telecom, Market access 10+yrs exp

Business Development Manager

Senior Medical Writer

Digital Content Manager

Senior Recruiter

Lead Systems Engineer – Risk

Application Support Engineer

Business Development Manager (Global Payments)

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