Specialist Regulatory Operations
4 weeks ago
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 a Specialist Regulatory Operations & Compliance support.
What You’ll Do:
- Co-ordination/management/lead XEVMPD/IDMP submissions, ensuring that electronic submissions meet the required quality standards with internal/external deadlines.
- Provide subject matter expertise on ISO IDMP Standards, EU Implementation Guide, and SPOR, ePI, PLM, PMS, IRIS implementation.
- IDMP operational strategy Leading and execution.
- Assistance in the development and implementation of new Regulatory processes and the continuous improvement thereof.
- Work closely across the company to implement, maintain, and ensure compliance of Electronic Document Management System, Publishing system and XEMPD/IDMP systems.
- Networking and awareness activities that leads to a continuous stream of impending changes in electronic regulatory requirements.
- Lead/manage XEVMPD/IDMP submissions creation maintenance and their QC and Compliance and All other XEVMPD/IDMP related activities.
- Responsible for tracking and communicating the progress of submissions to the wider Regulatory function.
- Responsible for IDMP related data migration, mapping, cleaning and data enrichment.
- Support systems projects by participating in system validation and implementation of IDMP.
- Participate in the migration of data between systems, as and when required.
- Support with the maintenance and development of XEVMPD/IDMP procedure documents (SOP/WI) of regulatory systems processes.
- Provide support and mentoring/training/troubleshooting to new systems users, by adopting a Super User/Process owner role for regulatory systems.
- Lead all the data management activities of SPOR, Master data (IDMP related).
- Responsible for providing the training, support, and the end user communication for data management topics and on IDMP intelligence.
- Ensure regulatory/system compliance with Regulatory Processes by performing spot checks of data and documentation in the Regulatory Systems.
- Assist in the development of a framework for resolution of compliance issues/risks
- Support Product and Company M&A, with respect to data migration.
- Ensure required portal and Gateway’s access to regulatory team along with training, e.g. PLM, IRIS, ESG.
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 submissions of XEVMPD and submissions to EMA via gateway, its maintenance.
- Hands on experience with validation/Implementing Regulatory systems for XEVMPD/ISO IDMP.
- Knowledge of Electronic submissions requirements globally. (Including XEVMPD/IDMP).
- Knowledge and hands on experience of electronic Document Management Systems (e.g. Veeva Vault RIM) and XEVMPD/IDMP tools.
- Good understanding of ICH and regional regulatory guidelines – should be able to interpret guidelines and apply them in practical situations.
- 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).
- Assertive & Good Influencing skills.
- 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.
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