Manager – Labelling
Company Name:-
Piramal Enterprises
Job Location:-
Mumbai, Maharashtra
Job Summary:-
JOB OVERVIEW:
The role is responsible for all Labeling components of Piramal Critical Care Products Worldwide to ensure compliance with innovator labeling, internal company, external partners, regulatory and serialization standards and requirements.
The incumbent may also participate in a cross-functional Promotional Review Committee to review advertising and promotional materials as necessary to ensure materials are accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations.
KEY STAKEHOLDERS: INTERNAL
Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Pharmacovigilance, Planning, Project Management, Senior Management
KEY STAKEHOLDERS: EXTERNAL
Country Distributors, Health Authority (HA), CMOs and external partners.
REPORTING STRUCTURE:
Role reports to: Regulatory Compliance Manager, Regulatory Affairs
Positions that report into this role: 3 Executive
EXPERIENCE:
Must possess Knowledge of US, EU and global regulatory labeling requirements.
Minimum 8 years labeling experience.
Additionally, must have at least 3 years experience managing direct reports.
Experience reviewing Advertising and Promotional Materials from a regulatory perspective preferred.
Experience working with Electronic Labeling Management systems such as Harmony preferred.
Experience working with electronic Document Management Systems such as MasterControl or Veeva Vault.
KEY RESPONSIBILITIES
Prepare labeling text and side-by-side documents in support of regulatory submissions (original dossier submissions, annual reports, supplemental filings/variations).
Initiate new/revised labeling in the Harmony artwork management system.
Provide review as per approved labeling requirements for the indicated market and entry of Health Authority and/or distributor approval of artworks.
Responsible for proofreading all types of label copy, annotation, etc.
at all development stages as well as final label copy to ensure accuracy of labeling.
Assign and manage workload for team members.
Prepare change control documents for labeling and artwork documentation.
Monitor and process innovator labeling updates for existing generic products and ens
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