Senior Executive - Regulatory Affairs

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Division Piramal Critical Care Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.   PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.   PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.  For more details, please visit https://www.piramalcriticalcare.com/global/  Job Title Senior Executive - Regulatory Affairs Job Description To handle all Regulatory filings and other assigned products with minimal supervision Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai Travel: Low   Job Overview: To support all products submissions including new applications, variations and renewals to ensure supplies to the EU & RoW markets in accordance with government legislation, relevant guidelines and national requirements.   Key stakeholders - Internal (Cross-Functional): Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Program Management, Artwork & Labeling Team   Key stakeholders - External (Country Distributors, Health Authorities (HA), external partners, CMO's)   Reporting structure: Directly reports to Manager - Regulatory Affairs   Essential Qualifications: M. Pharm/B. Pharm/MSc or equivalent in a relevant scientific discipline

Essential Experience: Minimum 3 to 5 years relevant experience in handling European markets with National procedures and in Rest of World territories.

Overall total experience in Regulatory of minimum 3-5 years

Roles and Responsibilities: Preparation and submission of 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, SmPC's, labelling etc. for compliance with all applicable regulations, local procedures and guidelines for assigned markets

Initiation of 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) received from Health Authorities in accordance with internal timelines and HA imposed deadlines

Review and approve response packages to Requests For Information (RFI) received from Health Authorities in accordance with internal timelines and HA imposed deadlines

Collaborate with Artwork team for labeling updates for assigned products and countries to ensure timelines remain on target.

Work with Artwork and Labeling teams for artwork changes and implementation (serialization projects, MA transfers, variations etc.)

Responsible for requests for complementary elements (CPPs, declarations, etc.)

Responsible for overall document management and regulatory data for assigned products

Collaborate with cross functional team to ensure overall project deliverables remain on time

Responsible for entering data into regulatory electronic file storage, activity trackers and databases or other systems to ensure prompt and accurate access to regulatory information (concerning current, pending and future activities (applications, variations renewals etc.) SmartSheet, SharePoint, MasterControl etc.)

Contribute to process efficiency improvements as process experts

Authors new or revised documents such as SOP's , SWI's etc.

Stay up to date with the latest rules and regulations

Provide updates on changes to the external regulatory landscape as laws, regulations and guidance changes

Provide routine updates on assigned activities and projects across the team

Aware of impact of any decisions made that impact the availability of safe and effective products to the customers worldwide .

Defines, develops regulatory submission strategies for new applications, complex variations and other submissions and agrees these with Senior leadership according to business priorities

Use effective communication skills and effective working relationships to ensure consistent quality of work.

People management Preparation and submission of regulatory documentation for new marketing authorisations, variations and renewals for assigned products and/or markets

Key Competencies: Excellent communication skills using both spoken and written English.

Proficient in the use of Microsoft Office especially Word and Excel.

Ready to take challenges in work 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 at attention to detail and 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.

Demonstrate good time management skills

Able to prioritise effectively and maintain excellent focus on assigned activities

Able to take ownership of assigned actions & tasks

Is responsible and accountable for assigned actions & tasks