Advanz Pharma Looking for Executive – Regulatory Affairs at Andheri, Mumbai, Maharashtra Full Time

Location: IN

Company: AdvanzPharma

Location: Andheri, Mumbai

(Hybrid working opportunity)

About ADVANZ PHARMA

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.

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 complement 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

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.

Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements.

What You’ll Do:
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.

Ensure informing stakeholders (internal & external) and request of document(s), information sufficiently ahead of time, proactively following up for timely delivery.

Detailed review of document to ensure it meets regulatory requirement.

Preparation of regulatory submission with a focus on right first time without any further review of 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 stakeholder in a timely fashion.

Plan and prioritise variation submissions based on 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.

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.

About You

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

For this role, you will also have the following:
Qualifications:
Formal Training in Regulatory Affairs.

Graduate/Post-Graduate in any discipline of science, preferably life science / Pharmacy.

Knowledge, Skills & Experience:
Significant experience of handling life cycle management of pharmaceuticals 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.

Why ADVANZ PHARMA?

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.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you’ll be empowered to own your work, explore new possibilities, and make things happen.

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.

To join us on our exciting journey, Apply now! *

• Please include a CV and Cover letter.