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Job Summary
Role Details
Regulatory Affairs Manager EMENA Pharmaceuticals
Role:Full-timePermanent
Location:Stockley Park London
Salary:Competitive bonus benefits
The Role
Wereseekingaproactive and meticulousRegulatory Affairs Manager to oversee ourRegulatorylifecycle activities(managing submissions regulatory changes internalcontrolsand data accuracy) ensuring our operationalprocessescomply withthe relevant Regulatory requirements and working with cross-functional teams to support business goals and product compliance. Managing a small team across 2 locationsyoulloversee an interesting diversified product portfolio (with different dosage forms productsizesand a mix of in-house and third-party manufacturing) with a primary focus on consolidatingand leadingour UK activities.
Overseeing the lifecycle management of our Marketing Authorisations (from submission of variations to product labellingchemistrymanufacturing controls(CMC) and post-authorisation amendments) youllplan and review your teamswork to ensure regulatory documents are submitted to the necessary timeline and quality standards and that all post-authorisation Regulatory commitments are completed in-line with applicable regulations and guidelines from the relevant health authorities (e.g. MHRA EMA). In additionyoullwork closely with internal cross-functional teams (e.g. R&D QA QC Supply Chain) to support business projects and priorities including across our international teams. To support the smooth running of the teamyoullmonitorour Regulatory IT systems including our in-house RIMS database and implementingappropriate QMSsystems with our affiliate organisations to ensure dataremainsaccuratecompliantand aligned to our corporate policies and local Regulatory thisdatato report on KPI metrics for senior managementand alsochampionprocess enhancements encourage knowledge sharing within your team and support affiliates to remain audit and inspection ready in collaboration with Regional Teams.
The Person
- Significant experience in a similar senior level Regulatory role within the pharmaceutical industry with a comprehensive understanding of all Regulatory lifecycle activities and an understanding of how Pharmacovigilance Quality and Compliance responsibilities align.
- In-depth knowledge of CMC (Chemistry Manufacturing and Controls) and EU regulations and experience of interacting with relevant Regulatory Authorities (e.g. MHRA).
- Well organised able to manage and prioritise multiple workstreams to deadline whilst ensuring the consistency accuracy and efficiency of activities even in a fast-paced and changeable environment.
- Experience managing mentoring and developing high performing teams.
- Excellent communication skills (written and spoken) able to liaise with people at all levels of authority navigate cultural differences and build effective working relationships.
- Good IT skills (including Microsoft Office) able to learn new systems quickly and familiar with overseeing RIMS QMS and eCTD systems for accuracy compliance and ensuring useful outputs.
- Degree-level qualification in a Life Science subject; a Regulatory Affairs Certification (RAC) beneficial.
The Rewards
In return we offer a competitive salary package (with bonus scheme) pensionschemeand 25 days holiday per year(plus bank holidays). We also offer a range of other benefits to support our teamincluding retailer discounts and healthcare options. Not to mention the opportunity to be part of a progressive and expanding business with increasing global reach.
How to Apply
A Bit About Us
Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive alwaysseekingto improve products and patients access to them. Accordisdriven to think differently and deliver more for the benefit of patients worldwide.
To continue our growthwerelooking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do we offer rewarding opportunities for those looking for continued personal and professional growth investing in training and development tailored toeach individualsfocus. So ifyourelooking for an inclusive company to take your career to the next levelyourecertainly in the right place; come and join us to make it better.
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All applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or disability.
Requisition ID: id
All applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or disability.
Requisition ID: 15547
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