Executive - Regulatory Affairs

Overview

Support regulatory submissions for the EU and Rest of World (RoW) markets, including new applications, variations and renewals, in line with government legislation, guidelines and national requirements.

What you'll do

• Prepare and submit regulatory documentation for new marketing authorisations, variations and renewals for assigned products and/or markets.
• Prepare and review all new applications and other submissions, including dossier components, SmPCs and labelling, for compliance with applicable regulations, local procedures and guidelines for assigned markets.
• Initiate change controls in applicable systems for all regulatory-driven change controls.
• Act as liaison between single or multiple project teams to obtain submission-related information.
• Author response packages to Requests for Information (RFI) from Health Authorities within internal timelines and Health Authority deadlines.
• Review and approve response packages to Requests for Information (RFI) from Health Authorities within internal timelines and Health Authority deadlines.
• Collaborate with the Artwork team on labelling updates for assigned products and countries to keep timelines on target.
• Work with Artwork and Labeling teams on artwork changes and implementation (serialization projects, MA transfers, variations etc.).
• Handle requests for complementary elements (CPPs, declarations, etc.).
• Manage overall document management and regulatory data for assigned products.
• Collaborate with cross-functional teams to keep overall project deliverables on time.
• Enter data into regulatory electronic file storage, activity trackers and databases (such as SmartSheet, SharePoint, MasterControl) to ensure prompt and accurate access to regulatory information on current, pending and future activities.
• Contribute to process efficiency improvements as a process expert.
• Author new or revised documents such as SOPs and SWIs.
• Stay up to date with the latest rules and regulations and provide updates on changes to the external regulatory landscape.
• Provide routine updates on assigned activities and projects across the team.
• Be aware of the impact of decisions on the availability of safe and effective products to customers worldwide.
• Define and develop regulatory submission strategies for new applications, complex variations and other submissions, and agree these with senior leadership according to business priorities.
• Use effective communication and working relationships to ensure consistent quality of work.

What you'll need

• M.Pharm, B.Pharm or MSc, or equivalent, in a relevant scientific discipline.
• Minimum 2 to 4 years of relevant experience in handling European markets and/or Rest of World territories.
• Excellent communication skills in spoken and written English.
• Proficiency in Microsoft Office, especially Word and Excel.
• Ready to take on challenges and manage priorities and deadlines.
• Able to work independently on multiple projects/tasks simultaneously.
• Excellent coordination and collaboration with other teams and departments globally.
• Good attention to detail; able to review documents and provide critical assessment of information and data.
• Excellent relevant technical knowledge from a scientific background, ideally within the pharmaceutical or allied industry.
• Good time management skills.
• Able to prioritise effectively and maintain excellent focus on assigned activities.
• Able to take ownership of assigned actions and tasks, and be responsible and accountable for them.

Details

• Location: Kurla, Mumbai.
• Travel: Low.
• Key stakeholders: external (country distributors, Health Authorities, external partners, CMOs) and internal (Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Program Management, Artwork & Labeling).