ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.
Post : Executive - Regulatory Affairs UK/IE
Job Description
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Executive- Regulatory Affairs.
• Planning and preparation for Renewals / annual maintenance of MA’s assigned; ensure all regulatory requirements of health authorities are met and supply continuity for the products are maintained.
• Assessing Change request assigned to ensure regulatory assessment along with strategy and documents required for any regulatory submissions are shared with stakeholder in a timely fashion.
• Following up on approval, prompt responses to any request for information ensuring timely approval and carrying out necessary post approval activities as defined in regulatory procedures.
• Ensure meeting other regulatory obligations like submission of Article 61 (3) updates, MAH Transfers, PSUR, Sunset clause applications as and when applicable, working cross functionally to get the necessary information for submissions and informing stakeholders about submission / outcome as per defined regulatory procedures.
• Ensure prompt action in terms of compliance to departmental procedures, ensure up to date training records for self, and regulatory databases are kept up-to-date as stipulated in internal procedures.
• Participate in continuous improvement initiatives, sharing ideas and thoughts, actively involved in implementation of such initiatives.
• Act as process owners for some simple regulatory procedures as and when delegated.
• Support Line Managers for readiness of any health authority inspection as and when delegated.
• Ensure timely completion of assigned Deviation and CAPAs
• Thrive in an entrepreneurial environment and take accountability for results.
• Embrace challenge and change, applying a growth mindset approach.
• Have a bias for action and fast decision making.
• Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
• Drive the spirit of “One Team” by working collaboratively across all business functions with an open, honest, and respectful cooperation.
• Contribute to making ADVANZ PHARMA a desired place to work.
Candidate Profile
• Formal Training in Regulatory Affairs.
• Graduate/Post-Graduate in any discipline of science, preferably life science / Pharmacy.
• Significant experience of handling life cycle management of pharmaceuticals in UK/IE/EU markets as an individual contributor.
• Good understanding and practical experience of working on CTD, specifically module 3 writing and review.
• Experience of handling Module 1 – understanding of application forms required during life cycle maintenance submission, understanding and good interpretation of labelling requirements and associated guidance.
• Experience of safety variation submissions – including writing/ review and handling RFIs
• Good understanding of ICH and regional regulatory guidelines – should be able to interpret guidelines and apply them in practical situations independently.
• Knowledge and experience of document management and change control system.
• Good Project Management and Communication skills.
• Pleasant personality with collaborative approach, interpersonal skills, high on team spirit
• Demonstrate sense of drive and urgency through work.
• Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented).
• A positive and ‘can-do’ approach, biased towards finding solutions and embracing change.
• Inspired by our values of entrepreneurship, speed and integrity.
• Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows.
• Work collaboratively across all business functions with an open, honest, and respectful cooperation.
• Ability to have fun and thrive in a growing, unique, and inclusive work environment.
Additional Information
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May 2024
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