Senior Executive, Regulatory Affairs, EU

This is a temporary position for 8 months.

ADVANZ PHARMA is a global pharmaceutical company with the purpose of improving patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network, complements our global operations.

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.

We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

About the Role

a Senior 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 is maintained.
  • Ensure informing stakeholders (internal & external) and requesting document(s), information sufficiently ahead of time, proactively following up for timely delivery.
  • Detailed review of the document to ensure it meets regulatory requirements.
  • Preparation of regulatory submission with a focus on right first time without any further review of the line manager, and ensure submission before due dates.
  • 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.
• Assessing Change request assigned to ensure regulatory assessment, along with strategy and documents required for any regulatory submissions, are shared with stakeholders in a timely fashion.
  • Plan and prioritise variation submissions based on the nature/ criticality of change using information available (for example, supply impact, compliance risk, etc).
• 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.
• Provide peer review support as and when required for submissions made by Executives and other Sr. Executives.
• Ensure prompt action in terms of compliance with departmental procedures, ensure up-to-date training records for self, and regulatory databases are kept up to date as stipulated in internal procedures.
• Actively drive continuous improvement initiative for team/ function as and when delegated.
• Actively drive simple to moderately complex regulatory projects (functional or cross-functional).
• Act as a process owner for simple to moderately complex regulatory procedures, ensuring the lifecycle of the procedure, taking ownership for engaging with the team to train and improve upon as and when needed.
• Support Line Managers for readiness and participation in any health authority inspection.
• To support/perform the submissions of the acquired products as part of acquisition and integration, as and when required, and their maintenance throughout the lifecycle.
• Ensure timely completion of assigned Deviations 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.

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives.

Knowledge, Skills & Experience:

• Significant experience in handling life cycle management of pharmaceuticals in the European region 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 systems.
• Good Project Management and Communication skills.
• Pleasant personality with collaborative approach, interpersonal skills, high on team spirit
• Demonstrate a sense of drive and urgency through work.
• Be able to make decisions based on facts available, trends, and suggest solutions to the 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.

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on.

But there s more to you and us than just work, which is why our culture, vision, and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

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