Specialist Regulatory Affairs EU

Location : Andheri, Mumbai

(Hybrid working opportunity)

About the Role

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

What You'll Do :

• Drive Integration activities following mergers & acquisition, taking responsibility for shaping up a process to integrate, generate regulatory intelligence needed during pre-integration assessments, support Unit Heads during due diligence activities, project manage integration by being a part of wider project team, carry out necessary regulatory submissions promptly as per project plan agreed to ensure smooth transition during transition period and eventually handing over responsibilities to respective life cycle management team at the end of transition period.
• Helping the Manager, the Regional team with review of applications made by the rest of the team, taking accountability for the right first time, ensuring high standards of review, and supporting the development of junior team members in the team. Review of regulatory submissions adding value through experience and knowledge / interpretation of available regulatory guidelines with an emphasis on no rejections, right first time, eliminating obvious and repetitive questions.
• Builds a strategy for complex regulatory submissions and drives discussions with health authorities as and when required to have an agreement on a regulatory strategy, keeping business interests in mind, and negotiates with health authorities when needed.
• If needed, handling complex regulatory submissions independently for the given regional portfolio with an emphasis on right first time to ensure timely approval and supply continuity.
• Act as process owner for complex regulatory / regulatory-driven cross-functional processes and look at process improvement / simplification.
• Responsible for keeping an oversight of, disseminating regulatory updates for respective regional authorities, and if needed, training / organizing discussions cross-functionally and contributing to legislative compliance.
• Act as a delegate for the Manager for cross-functional meetings like QRST, SNOP, etc. Act as approvers for change control / artworks in the manager's absence.
• Active participation in preparation and running any health authority inspection as and when needed.
• Coach junior members of the team on regulatory requirements as and when needed and be able to work on induction for new joiners of the team.
• Act as a deputy to the Manager / Sr. Manager during absences.

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 :

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

Knowledge, Skills & Experience :

• Significant experience in regulatory affairs working for life cycle maintenance activities in a doer / reviewer capacity in a pharmaceutical company in the UK / IE / EU markets as an individual contributor.
• Good understanding and practical experience of working on CTD, specifically module 2-3 writing and review.
• Commercial awareness of business and a good understanding of cross-functional dependency
• Knowledge of regional regulatory guidelines / CTD / ICH / eCTD.
• Strong Project Management and Communication skills.
• Pleasant personality with collaborative approach, strategic mindset, & Positive attitude.
• 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.

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 a Cover letter.

Skills Required

ectd, Project Management, Regulatory Affairs, Ich