Assistant Vice President - Pharma Labelling
- Genpact India
- 10 to 14 Yrs
- Mumbai
- 3 years ago
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Job Description
* With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us. Transformation happens here. Come, be a part of our exciting journey Are you the one we are looking for We are inviting applications for the role of Assistant Vice President - Pharma Labelling Specialist - Regulatory Affairs. This role is for a project manager in Pharma labelling and would involve driving projects in the area of regulatory framework and implement solution and drive transformation for the client. Responsibilities In this role, you will be responsible for all the activities related to- Monitoring and developing continuous improvement proposals on the processes.
- Maintain a staff of adequately skilled resources to meet deliverables.
- Communicate issues and resolve in an appropriate time-frame.
- Ensure adherence to agreed-to work practices.
- Meet established submission timelines and quality standards.
- Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labeling.
- Ensure collection of metrics required
- Maximize speed and minimize cost
- Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions.
- Guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. This may also include Regulatory Authority driven documents such as the Core Safety Profile.
- Ensure that client is up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles
- Project management to the Labeling Team throughout the entire process, from the decision to update a CDS/USPI/SPC through notification to partners in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.
- Advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.
- Masters in Lifesciences or equivalent with relevant experience in regulatory Affairs/Labeling or equivalent
- Demonstrated knowledge and understanding of CCDSs, US and EU labeling and the dynamics of Labeling Team purpose and objectives
- Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts
- Good knowledge of key regulatory and Labeling principles and SOPs
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in presenting to senior management when required
- Must be able to construct a Company Response (MAH response) for health authority questions
- Previous good client management experience required
- Global Exposure
Employement Category:
Employement Type: Full timeIndustry: BPO / Call Center
Role Category: R&D / Product Design
Functional Area: Not Applicable
Role/Responsibilies: Assistant Vice President - Pharma Labelling
Contact Details:
Company: Genpact IndiaLocation(s): Mumbai
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₹ 1.0 - 2.0 Lakh/Yr
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Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...
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