We are looking for a Regulatory Affairs Specialist - Global Lifecycle Management (LCM) to support and manage post-approval regulatory activities across global markets, ensuring compliance and timely maintenance of product licenses.
This role is pivotal in managing activities related to global lifecycle submissions, including variations, renewals, label updates, artwork changes, CMC updates, site transfers, and administrative maintenance. Collaboration with global Health Authorities, manufacturing sites, and internal cross-functional teams will be essential to ensure continuous regulatory compliance of marketed products.
Roles & Responsibilities
- Should have regulatory experience in lifecycle management activities for multiple markets especially in Europe
- Preparation, review, and submission of variations (Type IA/IB/II), renewals, notifications, and administrative updates for global markets including EU, UK, and RoW markets etc.
- You will be responsible for preparation and review of Module 1nd CMC variation documentation
- You will be responsible for preparation of product information updates (SmPC, PIL, labels) and review of artworks to ensure regulatory compliance.
- Direct interaction with global regulatory authorities (EU NCAs, MHRA, other countries health authorities officials as applicable).
- Handling of post-approval deficiencies/queries and providing timely responses to regulatory agencies.
- Good interpersonal skills with strong command of English to communicate with regulatory authorities & IL customers/partners.
- Providing regulatory guidance and regulatory strategies to CMO's and other cross-functional teams for post-approval changes.
- Support manufacturing sites during regulatory audits, inspections, and compliance-related queries.
- You will be responsible for monitoring and follow-up of product lifecycle submissions for early and timely approvals.
- You will be responsible for updating and maintaining regulatory databases, tracking tools, and submission logs.
- You will be responsible for participating in industry associations to keep abreast of global post-approval regulatory requirements.
- You will be responsible for creation and revision of new or existing SOPs related to lifecycle management.
- You will be responsible for maintaining strong relationships with global health authorities and regulatory stakeholders.
- You will be responsible for delivering lifecycle management goals with minimum supervision.
- You will be responsible for performing other tasks and duties assigned by the immediate supervisor.
Educational qualification: M.pharm
Minimum work experience: 4 plus years of experience in regulatory affairs preferably in Europe Lifecycle management activities
Skills & attributes:
- Knowledge of EMA guidelines.
- Proficiency in spoken and written English.
- Proficiency in using a computer and its applications, specifically Google Applications and MS Excel.
- Excellent interpersonal and communication skills.
- Attention to detail and the ability to multi-task and meet strict deadlines.
