Specialist - Regulatory Affairs, EU @ Commentsold

Job Description

Date: 29 Mar 2024 Location: Andheri (East), IN, Mumbai 400 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 PHARMAs 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 Specialist- Regulatory Affairs. What Youll 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, Regional team with review of applications made by rest of team taking accountability for right first time, ensure high standards of review and support development of junior team members in 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 strategy for complex regulatory submissions and drive discussions with health authorities as and when required to have an agreement on a regulatory strategy keeping business interest in mind, negotiate 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 of regulatory updates for respective regional authorities and if needed training/ organizing discussions cross functionally and contribute to legislative compliance. Act as delegate for Manager for cross functional meetings like QRST, SNOP etc. Act as approvers to change control/artworks in absence of manager. 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, be able to work on induction for new joiners of the team. Act as a deputy to 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 of regulatory affairs working for life cycle maintenance activities in doer/reviewer capacity in pharmaceutical company in 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 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 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, youll be empowered to own your work, explore new possibilities, and make things happen. But theres 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 Womens 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

Employement Category:

Employement Type: Full time
Industry: Medical / Healthcare
Role Category: Medical / Healthcare
Functional Area: Not Applicable
Role/Responsibilies: Specialist - Regulatory Affairs, EU

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Keyskills:   Regulatory Affairs Regulatory intelligence Due diligence Project management Regulatory submissions Process improvement Change control Coaching Project Management Communication skills Commercial awareness CTD ICH Collaboration Entrepreneurship Integrity Integration activities Review of applications Health authorities negotiations Legislative compliance Health authority inspection eCTD Cross functional dependency Strategic mindset Positive attitude Learning agility Speed