Are you the one we are looking for?
We are inviting applications for the role of Manager or Senior Manager, Regulatory affairs Submission Management.
Leading project teams, ensuring maintenance of team records and process-related documentation i.e process maps, job aids, project trackers, checklists, etc.
Responsible for implementing regulatory submission strategies for assigned pharmaceutical products in accordance with global regulations, guidance along with monitoring the overall performance, timeliness and compliance of the submission packages for global submissions
It includes regulatory assessment; preparation and quality review of pre & post approval regulatory submission dossiers; and compliance activities
Extensive experience in end-to-end life-cycle management of pharmaceuticals for EU, US and ROW markets for a vast range of therapeutic areas.
Management of 3 handbooks including the maintenance & updation of department process documentation to reflect change in-process or guidance
Experience with CTAs and CMC and general life cycle : CTA applications experience & Coordinating CMC lifecycle submissions (not just working on content)
Ability to lead client meetings and managing project governance.
Deliver on agreed SLAs with clients at contract and account / project level. Meet all monthly reporting / business metrics / KPIs requirements and manage internal control processes.
Planning the project by understanding the client needs, channelizing appropriate resources, managing project deliverables and providing solutions in real time.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Ability to prioritize & execute the project according to the project plan / timelines / schedules.
Ensure established policies and procedures of the organization / client are followed and ensure compliance.
Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
Contribute to draft Request for information and / or Request for proposals for new client / business opportunities. Provide inputs to project regulatory strategies by performing assessments of changes, identifying global regulatory requirements and critically evaluate supporting documentation to assess acceptability and identify potential risks.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
Demonstrated effective leadership, communication, and interpersonal skills.
Qualifications we seek in you!
Bachelor's or master’s degree required in science, engineering or related field (advanced degree preferred).