Current jobs related to Regulatory Affairs Specialist - London Area - SUN PHARMA

  • Regulatory Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Specialist - Chemical Compliance ExpertWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at VRS Regulatory. As a key member of our regulatory affairs team, you will be responsible for providing expert advice on chemical regulatory compliance and ensuring that our clients' products meet the necessary regulatory...

  • Regulatory Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Specialist - Chemistry/Analytical MethodsWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at VRS Regulatory. As a key member of our regulatory affairs team, you will be responsible for providing expert advice on substance and product registrations strategies, reviewing phys-chem data packages, and facilitating...

  • Regulatory Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Specialist OpportunityVRS Regulatory is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory advice to clients in the chemical regulatory science consultancy sector.Key Responsibilities:Providing clients with regulatory...

  • Regulatory Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Specialist OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at VRS Regulatory. As a key member of our Regulatory Affairs and Risk Assessment division, you will play a crucial role in ensuring compliance with EU 1107/2009 regulations for plant protection products.Your primary responsibilities will...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Career OpportunityVRS Regulatory is seeking a highly skilled Regulatory Affairs Specialist to join our team in delivering regulatory services related to chemistry and analytical methods for plant protection products.Key Responsibilities:Provide regulatory advice to clients on substance and product registrations strategies.Review phys-chem...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    An exciting opportunity to lead regulatory strategy for plant protection products has become available within VRS Regulatory.As a Regulatory Affairs Specialist, you will be responsible for developing and implementing regulatory strategies for our product portfolio in specific geographical territories. This will involve managing a portfolio of plant...

  • Regulatory Affairs Strategist

    5 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionAs a Regulatory Affairs Specialist at VRS Regulatory, you will have the opportunity to develop and implement regulatory strategies for plant protection products in specific geographical territories. Your key responsibilities will include managing a portfolio of plant protection products, developing regulatory submissions, and working with the...

  • Regulatory Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Key Responsibilities:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy for the product portfolio in your territoryPrepare and review regulatory submissionsWork with the in-house regulatory science team to produce technical dossier sections and risk assessmentsSubmit regulatory applications and...

  • Regulatory Affairs Manager

    3 weeks ago

    London, Greater London, United Kingdom Turner Regulatory Full time

    Regulatory Affairs ManagerTurner Regulatory is seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will have a background in European Market Regulatory activity and excellent commercial awareness.Key Responsibilities:Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch,...

  • Regulatory Affairs Director

    3 weeks ago

    London, Greater London, United Kingdom Reed Specialist Recruitment Ltd Full time

    Regulatory Affairs ManagerReed Specialist Recruitment Ltd is seeking an experienced Regulatory Affairs Manager to oversee and manage the regulatory affairs team for a global healthcare provider based in the North West of the UK.Main Responsibilities:Regulatory Strategy: Develop and implement regulatory strategies aligned with the company's strategic...

  • Regulatory Affairs Director

    4 weeks ago

    London, Greater London, United Kingdom Reed Specialist Recruitment Ltd Full time

    Job Title: Regulatory Affairs DirectorWe are seeking an experienced Regulatory Affairs Director to lead our regulatory affairs team. The successful candidate will be responsible for developing and implementing regulatory strategies aligned with our company's strategic objectives.Main Responsibilities:* Develop and implement regulatory strategies* Lead and...

  • Regulatory Affairs Specialist

    3 weeks ago

    London Area, United Kingdom Warman O'Brien Full time

    Warman O'Brien is seeking a Regulatory Affairs Specialist to join their team in the UK. The successful candidate will be responsible for ensuring the company's generic products remain compliant with relevant legislation.The ideal candidate will have 7+ years of experience in pharmaceutical regulatory affairs, with a focus on small molecule...

  • Pharmacovigilance and Regulatory Affairs Specialist

    3 weeks ago

    London Area, United Kingdom Chugai Pharma Europe Full time

    Job Title: Pharmacovigilance and Regulatory Affairs SpecialistChugai Pharma Europe is seeking a highly skilled Pharmacovigilance and Regulatory Affairs Specialist to join our team in London. As a key member of our Regulatory and Pharmacovigilance Department, you will be responsible for ensuring the data triage, processing, and submission of adverse events,...

  • Pharmacovigilance and Regulatory Affairs Specialist

    3 weeks ago

    London Area, United Kingdom Chugai Pharma Europe Full time

    Job Title: Pharmacovigilance and Regulatory Affairs SpecialistChugai Pharma Europe is seeking a highly skilled Pharmacovigilance and Regulatory Affairs Specialist to join our team in London. As a key member of our Regulatory and PV Department, you will be responsible for ensuring the data triage, processing, and submission of adverse events, collaborating...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, Greater London, United Kingdom Skinandme Full time

    {"title": "Regulatory Affairs Specialist", "description": "Regulatory Affairs SpecialistWe're seeking a highly skilled Regulatory Affairs Specialist to join our team at Skin + Me. This role will be responsible for leading the regulatory strategy for our products, ensuring compliance with relevant laws and regulations.About the Role:The ideal candidate will...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, Greater London, United Kingdom Skinandme Full time

    {"title": "Regulatory Affairs Specialist", "description": "Regulatory Affairs SpecialistWe're seeking a highly skilled Regulatory Affairs Specialist to join our team at Skin + Me. This role will be responsible for leading the regulatory strategy for our products, ensuring compliance with relevant laws and regulations.About the Role:The ideal candidate will...

  • Public Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom Rud Pedersen Public Affairs Full time

    Job Title: Public Affairs SpecialistWe are seeking a highly motivated and experienced Public Affairs Specialist to join our team at Rud Pedersen Public Affairs in London. As a Public Affairs Specialist, you will be responsible for building and maintaining relationships with key stakeholders, developing and implementing effective public affairs strategies,...

  • Regulatory Affairs Director

    2 weeks ago

    London, United Kingdom Reed Specialist Recruitment Ltd Full time

    Job Title: Regulatory Affairs ManagerJob Reference: TPBN1_UKTJLocation: North-West, UKJob Type: Full time & permanentJob Category: HealthcareAbout the Company: Reed Specialist Recruitment LtdAbout the Role:Regulatory Strategy:Develop and implement regulatory strategies aligned with the company's strategic objectivesTeam Leadership:Lead, support, and develop...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, Greater London, United Kingdom GlaxoSmithKline Full time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for ensuring the development of appropriate regional regulatory strategies and their execution for assigned assets.Key Responsibilities:Develop and...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, Greater London, United Kingdom GlaxoSmithKline Full time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for ensuring the development of appropriate regional regulatory strategies and their execution for assigned assets.Key Responsibilities:Develop and...

Regulatory Affairs Specialist

2 months ago

London Area, United Kingdom SUN PHARMA Full time

Job Summary:

Sun Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the compliance of our pharmaceutical and medical products with regulatory requirements in the UK market.

Key Responsibilities:

  • Liaise with internal and external partners to ensure timely receipt of necessary documents, including those from R&D, RA, and artwork departments, as well as translations services and consultants.
  • Prepare SmPC, labeling, and PILs texts according to the Quality Review of Documents (QRD) format.
  • Verify the technical content of product information documents.
  • Proofread artwork for packaging materials.
  • Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications.
  • Maintain the life cycle management of dossiers or approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
  • Liaise with regulatory colleagues in country offices, corporate groups, and competent authorities (MHRA) and third parties on regulatory issues.
  • Collaborate with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, and Sales.
  • Maintain RA archives (electronically).
  • Ensure Regulatory Information is correct and accessible for other stakeholders.
  • Work with required IT standards, such as eCTD, XEVMPD.
  • Work with corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR.
  • Determine and write standard operating procedures.

Requirements:

  • Bachelor or Master Degree (preferably in Life Sciences, Languages, or Law).
  • Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines).
  • Understanding of the drug development process.
  • Able to comply with company standard operating procedures.
  • Good verbal and written communication skills in English.
  • Good IT skills, including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA, and CBG portal.
  • Excellent attention to detail.
  • Good time management skills.
  • Good organization and project management skills.
  • Good interpersonal and team working skills.
  • Presentation skills and experience of delivering training.