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Mae'r hysbyseb swydd hon wedi dod i ben ac mae'r ceisiadau wedi cau.
Associate Director, Regulatory Biologics
| Dyddiad hysbysebu: | 16 Gorffennaf 2024 |
|---|---|
| Cyflog: | £50,000 bob blwyddyn |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 15 Awst 2024 |
| Lleoliad: | TW208RN |
| Gweithio o bell: | Hybrid - gweithio o bell hyd at 3 ddiwrnod yr wythnos |
| Cwmni: | Essential Pharma Ltd |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: |
Crynodeb
Associate Director, Regulatory Biologics
Essential Pharma are looking for an Associate Director to bring deep knowledge of biologics products to manage the global regulatory aspects of this exciting, growing portfolio area. Apply Today!
What You Will Do
• Reporting into the RP, Senior Director QA, RA, PV, you will lead your own regulatory projects with a focus on biologic products, either in the rare disease or other indications, working to strict deadlines.
• Action and coordinate regulatory affairs activities both in-house and through our partners.
• Provide regulatory expertise to technical projects, ensure compliance at contract manufacturing sites is maintained and the development of product information including product artwork is delivered.
• Lead on support for both acquisition and integration of new products into the portfolio and organic growth of the existing portfolio.
• Work with a range of stakeholders including the broader regulatory team and PV to resolve issues, manage regulatory processes and ensure your knowledge of relevant regulations, especially as it relates to biologic pharmaceutical products, is shared to ensure we are developing knowledge across the business.
What We Do
Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.
We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.
Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office, five minutes’ drive from Egham Train Station situated on the Thorpe Industrial Estate. We also have colleagues based in Malta, France, Spain and Switzerland.
What You Will Bring
• Sciences degree coupled with a professional qualification e.g. a registered pharmacist.
• Deep knowledge of global regulatory affairs working with biologic pharmaceutical products, US markets experience is particularly relevant.
• Eligibility to live and work in the UK.
What We Offer
• Salary – from £50,000
• Agile Working – we offer flexibility and trust from day one, when you attend the office will be guided by business needs and role requirements. This role requires you to work a least one day per week from our Egham, Surrey office with flexibility for business needs and company events.
• £150 towards your home office – claim purchases back on expenses.
• Healthcare Insurance
• Pension – you contribute 5% and we offer 3%.
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
• Enhanced Family Leave
• Enhanced Sick Pay
• Annual Leave – 26 days plus bank holidays, 3 days shut down between Christmas and NY.
• Discretionary Annual Performance Bonus
• Referral Programme - £1500 for a successful hire!
• Recognition Programme – from shout outs, vouchers and up to £2000 for gold awards!
What To Expect
• We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.
• Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.
• Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.
Essential Pharma are looking for an Associate Director to bring deep knowledge of biologics products to manage the global regulatory aspects of this exciting, growing portfolio area. Apply Today!
What You Will Do
• Reporting into the RP, Senior Director QA, RA, PV, you will lead your own regulatory projects with a focus on biologic products, either in the rare disease or other indications, working to strict deadlines.
• Action and coordinate regulatory affairs activities both in-house and through our partners.
• Provide regulatory expertise to technical projects, ensure compliance at contract manufacturing sites is maintained and the development of product information including product artwork is delivered.
• Lead on support for both acquisition and integration of new products into the portfolio and organic growth of the existing portfolio.
• Work with a range of stakeholders including the broader regulatory team and PV to resolve issues, manage regulatory processes and ensure your knowledge of relevant regulations, especially as it relates to biologic pharmaceutical products, is shared to ensure we are developing knowledge across the business.
What We Do
Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.
We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.
Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office, five minutes’ drive from Egham Train Station situated on the Thorpe Industrial Estate. We also have colleagues based in Malta, France, Spain and Switzerland.
What You Will Bring
• Sciences degree coupled with a professional qualification e.g. a registered pharmacist.
• Deep knowledge of global regulatory affairs working with biologic pharmaceutical products, US markets experience is particularly relevant.
• Eligibility to live and work in the UK.
What We Offer
• Salary – from £50,000
• Agile Working – we offer flexibility and trust from day one, when you attend the office will be guided by business needs and role requirements. This role requires you to work a least one day per week from our Egham, Surrey office with flexibility for business needs and company events.
• £150 towards your home office – claim purchases back on expenses.
• Healthcare Insurance
• Pension – you contribute 5% and we offer 3%.
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
• Enhanced Family Leave
• Enhanced Sick Pay
• Annual Leave – 26 days plus bank holidays, 3 days shut down between Christmas and NY.
• Discretionary Annual Performance Bonus
• Referral Programme - £1500 for a successful hire!
• Recognition Programme – from shout outs, vouchers and up to £2000 for gold awards!
What To Expect
• We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.
• Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.
• Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.