Add office photos
All Filters
285 Novartis Jobs
RA CMC Senior Manager
Novartis
posted 17d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Independently provide strategic and operational global CMC regulatory direction and documentation for projects/products covering development, registration and approval/post approval activities. Make informed regulatory decisions, balancing patient and business risks and benefits leading to timely Health Authority approvals.
About the Role
Major Accountabilities:
- Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance
- Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stake holders. Represent department in cross-functional project teams as appropriate.
- Lead, prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
- Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA.
- Represent department on due diligence teams for in-licensing and divestment opportunities.
Key Performance Indicators (KPIs):
- Produces high quality strategic project documentation and presentations (e.g., project plans, documentation, Risk Management Assessments, lessons learned, etc.); no late changes in strategy due to inadequate prior evaluation.
- Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control.
- Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders; changes in project status communicated as required.
- RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
- Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
- Builds and maintains collaborative partnerships with stakeholders.
Education / Language / Experience:
Minimum: Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable: Advanced Science Degree
Languages :
Fluent English required (oral and written). Excellent written/spoken communication skills
Experience :
- Minimum 5 years in regulatory preferred, and/or experience in the pharmaceutical industry.
- Working knowledge/experience in regulatory submission and approval processes.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of product development and life cycle desirable.
- Demonstrated track record to successfully work in interdisciplinary global teams; leading, planning and prioritizing activities simultaneously on multiple projects.
- Ability to work independently and successfully with global project teams and prioritize activities considering timelines and workload.
- Effective planning, organizational and interpersonal skills.
- Computer/IT systems literacy
Employment Type: Full Time, Permanent
Read full job descriptionNovartis Interview Questions & Tips
Prepare for Novartis Senior Manager roles with real interview advice
What people at Novartis are saying
Rating based on 14 Senior Manager
reviews
Anonymous · Consulting
in Hyderabad / Secunderabad
Likes
Good work life balance
- Work-life balance - Good
Dislikes
Novartis as an organization is now going down the dumps owing to non value added work work and extreme politics - irrespective of their communications team trying their best to showcase a jazzy culture. Stay away if you have better alternatives..
- Skill development - Bad+4 more
Senior Manager salary at Novartis
reported by
157
employees
with 7-19
years exp.
₹19
L/yr - ₹50
L/yr
75%
more
than the average Senior Manager Salary in India
View more details
What Novartis employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
View more benefits
Compare Novartis with
GlaxoSmithKline Pharmaceuticals
Compare
Sun Pharmaceutical Industries
Compare
Cipla
Compare
Dr. Reddy's
Compare
Pfizer
Compare
Biocon Limited
Compare
Aurobindo Pharma
Compare
Lupin
Compare
Zydus Lifesciences
Compare
Torrent Pharmaceuticals
Compare
Viatris
Compare
Abbott
Compare
Alkem Laboratories
Compare
Ipca Laboratories
Compare
Glenmark Pharmaceuticals
Compare
Akums Drugs & Pharmaceuticals Limited
Compare
DIVI'S Laboratories
Compare
Piramal Group
Compare
Sanofi
Compare
Fresenius Kabi
Compare
Similar Jobs for you
Novartis Hyderabad / Secunderabad Office Location
Hyderabad Office
Novartis, Salarpuria-Sattva Knowledge City, Madhapur, Madhapur, Inorbit Mall Rd, Silpa Gram Craft Village, HITEC City
Hyderabad
Telangana 500081
Telangana 500081
Senior Expert, Science & Technology (EPM Specialist)
3-8 Yrs
Hyderabad / Secunderabad
Share an Interview