Manager, Regulatory Affairs -Labeling Nalanda Corporate Services

5.0 - 9.0 years

4 - 9 Lacs

Hyderabad

Work from Office

Experienced in pharmaceutical RA labeling, cGMP/FDA/CFR compliance, SPL creation, proofreading, and DSCSA. Skilled in MS Office, Adobe, TrackWise, SharePoint, and graphic design. Knowledge of label lifecycle, drug listing, and patent carve-outs.

Posted 2 months ago

Apply

Global Labelling Lead Indegene

6 - 11 years

17 - 19 Lacs

Hyderabad, Pune, Bengaluru

Hybrid

Role & responsibilities 8-10 years of core global labeling experience Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels. Demonstrates knowledge and understanding of company Core Data Sheets (CDS) and the dynamics of Labelling Team purpose and objectives. Demonstrates ability to understand how updating one section of a label may impact another and to propose recommendations to the Labelling Team. Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effective means of communication Demonstrates ability to influence and negotiate where necessary, across a highly matrixed team. 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. Ability to interact effectively with all levels/roles of project team members. Ability to manage time effectively across all projects, and work on many tasks in parallel. Takes ownership and accountability for assigned projects. Proven ability to effectively lead project team members in order to resolve issues. Consistent ability to foster strong matrix team working relationships. Proven track record of facilitating groups of individuals to work together on creating solutions. Proven ability to make sound decisions. Interfaces directly with senior management as appropriate on prescribing information content and requirements. Independently seeks to resolve problems in a proactive manner. Proven understanding of the dynamics and purpose of the companys CDS; experience in reviewing and understanding of implications of the CDS. Possesses advanced knowledge of external labeling guidelines and regulations and internal labeling policies and procedures. Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts. Demonstrates ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages. Demonstrates ability to develop strong and positive working relationships across multiple cultures and within global environment. Must have: 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.

Posted 2 months ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.