Posts Tagged ‘Regulatory Affairs Jobs’

Associate Director Regulatory Affairs Job in London

Monday, January 23rd, 2012

Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to join a hugely successful pharmaceutical company based in London.

 

Associate Director Regulatory Affairs Job Description

As Associate Director Regulatory Affairs you will responsible for the regulatory support of Oncology products by planning, managing and executing regulatory activities across the European territories for both investigational and marketed oncology products. You will also be involved in the development of innovative regulatory strategies for product development and approval of assigned oncology products.

Further responsibilities of this Associate Director Regulatory Affairs position include:

  • Provide regional regulatory strategic guidance on assigned oncology development and marketed products.
  • Plan, manage and execute regulatory activities in European territories as required on assigned oncology products.
  • Serve as regional regulatory representative on relevant multi-functional team meetings.
  • Advise functional areas regarding content requirements for regulatory submissions in the region and review documents for regulatory submission as required.
  • Interface and work closely with EU counterparts to ensure clinical and commercial alignment to support regulatory activities on assigned projects.
  • Manage and conduct meetings with regulatory authorities.
  • Act as a point of contact for regulatory authorities for submissions on assigned projects.
  • Evaluate new and revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
  • Undertake due diligence activities.
  • Draft EU regulations/guidance and coordinate organisationa lreview of these/collate comments for feedback to industry

 

As Associate Director Regulatory Affairs you will have the following qualifications, skills and experience:

  • Life sciences degree.
  • Pharmaceutical/biological drug development experience.
  • Proven European submissions capability, ideally in both pre-submission and  post authorisation activities which must cover oncology experience.
  • Experience in interactions with European Regulatory authorities in relation to all aspects of Regulatory activities.
  • Detailed knowledge of EU regulations and guidelines on drug development and submissions.
  • Knowledge of eCTD.
  • Good negotiation and communication skills and the ability to work independently and function well in a team orientated environment.

 

How to apply:

Click here to apply now.

For more information, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com.  Please quote reference CL23541 in all correspondence.

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Regulatory and Medical Affairs Officer Job in Watford

Tuesday, January 17th, 2012

Meera Pattni at CK Regulatory is currently recruiting for a Regulatory and Medical Affairs Officer to join a growing pharmaceutical company based in Watford, Hertfordshire.

 

Regulatory and Medical Affairs Officer Job Description

As Regulatory and Medical Affairs Officer, you will be responsible for maintaining marketing authorisations for both UK and Ireland to meet regulatory requirements. You will also provide a medical information service and monitoring/reporting of Pharmacovigilance cases to meet regulatory and legislative requirements.

Further responsibilities of this Regulatory and Medical Affairs Officer position include to:

  • Respond to medical and product enquiries received from healthcare professionals and members of the public.
  • Receive spontaneous reports of adverse events, follow up adverse events, communicate adverse events information to the central Pharmacovigilance department and report adverse event information to relevant regulatory authorities.
  • Receive, follow up, report and monitor customer complaints.
  • Review advertising and promotional material to ensure its compliance with relevant legislation and codes of practice.
  • Prepare and present Pharmacovigilance and ABPI training for both head office and field based staff.
  • Licence maintenance for existing marketing authorisations in the UK and Ireland.
  • Assist in compiling new MAA for UK and Ireland.
  • Coordinate artwork amendments and tracking of packaging modifications by liaising with appropriate personnel.
  • Prepare, submit and follow up applications for export certificates to the MHRA/IMB.
  • Compile, maintain and work to SOPs.

 

Qualifications, experience and skills required for this Regulatory and Medical Affairs position:

  • Previous experience within either medical or regulatory affairs is essential.
  • Knowledge of licence renewals beneficial.
  • Experience liaising with regulatory authorities required.
  • Life sciences degree essential.
  • Excellent interpersonal skills.
  • Ability to work independently.

 

How to apply:

Click here to apply online now.

For more information, please contact Meera Pattni at CK Regulatory on +44 (0) 1438 870024 or email mpattni@ckregulatory.com.  Please quote reference CL23491 in all correspondence.

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Give your advice to entry level Regulatory Affairs candidates…

Wednesday, January 4th, 2012

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Regulatory Affairs Professional Job based in Cambridge, UK

Wednesday, November 23rd, 2011

An outstanding opportunity for a Regulatory Affairs professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business. You will be responsible for identifying and developing new business to ensure the regulatory sales targets are met or exceeded.

The person

Suitable candidates will have a background in sales / marketing of a scientific consultancy service. You will have sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.

You must have excellent communication skills, be a good listener, be commercially minded and able to develop complex and diverse proposals / solutions for clients’ requirements.

You will have the ability to network with colleagues and co-workers appropriately and to manage the communication to and collaboration of decision-making members of each project team. 

Typical activities may include:

  • Providing regulatory strategy and technical consultancy for the Regulatory Affairs Business Development Team and Project Management Team as well as regulatory consultancy and strategic advice to the clients;
  • Reviewing and providing technical advice to prepare regulatory submissions;
  • Contributing to development and implementation of global and regional regulatory functions;
  • To assist in business development in securing new business and making presentations to clients;
  • Maintaining and developing relationships with existing customers via meetings, telephone calls and emails;
  • Visiting potential customers to prospect for new business;
  • Acting as a contact between a company and its existing and potential markets;
  • Negotiating the terms of an agreement and closing sales;
  • Gathering market and customer information;
  • Representing the organization at trade exhibitions, events and demonstrations;
  • Negotiating variations in price, delivery and specifications with managers
  • Advising on forthcoming product developments and discussing special promotions;
  • Liaising with Project Managers to check on the progress of existing orders;
  • Recording sales and order information and sending copies to the sales manager;
  • Reviewing own sales performance, aiming to meet or exceed targets;
  • Gaining a clear understanding of customers’ businesses and requirements.    

Offer:

• Competitive basic salary
• Attractive commissions package with no caps
• Bonuses 

 

How to apply:

Please reply with your CV and cover letter to jobs@elc-group.com

Location: Cambourne, Cambridge

Ref: RABD_1

Survey: Advice for entry level Regulatory Affairs candidates

Tuesday, November 22nd, 2011

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Associate Director of Regulatory Affairs Job in London

Monday, November 14th, 2011

Meera Pattni at CK Regulatory is recruiting for an Associate Director of Regulatory Affairs to join a successful pharmaceutical company based in London.

The role:

As Associate Director of Regulatory Affairs you will be required to plan, manage and execute regulatory activities related to global regulatory leadership for one or more projects. In addition, you will also provide regulatory therapeutic area strategic guidance on development projects and marketed products. Further responsibilities will include:

  • Manage and hire therapeutic area product development regulatory affairs staff.
  • Act as regulatory contact person for global project team on selected products.
  • Act as regional therapeutic area regulatory representative for specific project and products.
  • Prepare monthly reports detailing any development activities.
  • Responsible for due diligence and feasibility assessments of candidates in a therapeutic area.

 

The ideal candidate:

Meera is looking for candidates with the following skills, experience and qualifications:

  • Life sciences degree.
  • Previous line management experience.
  • Pharmaceutical industry knowledge essential.
  • Experience within regulatory affairs.

 

How to apply:

For more information or to apply for this Associate Director of Regulatory Affairs position, please contact Meera Pattni at CK Regulatory on +44 (0) 1438 870024 or email mpattni@ckregulatory.com.

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Regulatory Documentation Publisher Job in Basel

Thursday, November 3rd, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Regulatory Documentation Publisher to join a pharmaceutical company based in Basel.

The role:

As the Research Regulatory Documentation Publisher you will be required to support the submission process of scientific documents to the appropriate regulatory team. The publisher will be responsible for preparing scientific reports for regulatory submission use while supporting the department submission coordinator.

Responsibilities:

  • Coordinating the different positions throughout the process of releasing internal scientific documents to Health Authority submissions requesting Clinical Trials.
  • Formatting scientific reports in MS Word by applying corporate formatting standards.
  • Ensuring timely input from authors & other positions and incorporating their input into appropriate documents.
  • Managing quality control on selected reports at different stages of the process.

 

The ideal candidate:

Meera is looking for candidates with the following skills, experience and qualifications:

  • Excellent communication skills in both written and oral English.
  • Ability to manage multiple projects at once.
  • Ability to work to deadlines.
  • Proficiency in MS Word.
  • Strong attention to detail.
  • Willingness to think independently and take a flexible approach to documentation.

 

How to apply:

For more information or to apply for this Regulatory Documentation Publisher position, please contact Meera Pattni at CK Regulatory on 01438 743047 or email mpattni@ckregulatory.com. Please quote reference CL23069 in all correspondence.

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Regulatory Affairs Officer Job in West Yorkshire, UK

Tuesday, November 1st, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Regulatory Affairs Officer to join a pharmaceutical company which specialises in the development and marketing of oral liquid medicines.

The role:

As Regulatory Affairs Officer you will help to collate documents in preparation for variations and Marketing Authorisation Applications.

Main responsibilities:  

  • Advise departments of regulatory information regarding approved shelf life, suppliers etc.
  • Help collate documents for Marketing Authorisation Applications.
  • Prepare type I and II variations.
  • Apply for Export Certificates including legislation and notarisation as necessary.
  • Regulatory administrative tasks.
  • Initiation of packaging around the internalsystem and initial checks.

 

The ideal candidate:

Meera is looking for candidates with the following qualifications, skills and experience:

  • Life sciences degree.
  • Previous experience within regulatory affairs highly desirable.
  • Ability to work to deadlines.
  • Good written language skills.
  • Ability to solve problems.

 

How to apply:

For more information or to appy for this Regulatory Affairs Officer position, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23048 in all correspondence.

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Regulatory Affairs Engineer Job in West Sussex

Monday, October 17th, 2011

Meera Pattni at CK Regulatory is recruiting for a Regulatory Affairs Engineer to be based in West Sussex.

The role:

As Regulatory Affairs Engineer, you will support the Quality and Regulatory Affairs Manager in achieving regulatory goals and objectives by proactively supporting the organisation in achieving the necessary regulatory submissions for the targeted markets. In addition, you will also be required to develop and maintain worldwide regulatory knowledge in the preparation of regulatory submissions and registrations.

Main responsibilities:

  • Identify and provide advice and guidance on worldwide regulations throughout the organisation to ensure that up to date knowledge is maintained and implemented.
  • Control the preparation and maintenance of submissions to regulatory authorities for all targeted markets.
  • Collaborate with Compliance Engineers to provide Regulatory advice and guidance.
  • Support Business Units and Distributors world wide during the tendering process byproviding supporting documentation and certification including Manufacturers Declarations.
  • Provide regulatory determinations when required by CFR committees.
  • Perform regulatory review on business documentation.
  • Liaise with regulatory authorities.
  • Advise on installation issues relating to new product development and the installed base.

 

The ideal candidate:

Meera is looking for candidates with the following skills and experience:

  • Ability to interpret, adapt and provide guidance on product registration.
  • Proven track record in regulatory affairs.
  • Good communication skills.
  • Previous experience within medical devices.

 

How to apply:

For more information or to apply for this Regulatory Affairs Engineer position, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22950 in all correspondence.

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Associate Director of Regulatory Affairs Job in North West, UK

Tuesday, October 11th, 2011

Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to be based in the North West of England.

Responsibilities:

  • Direct and prepare regulatory submissions as required for global approvals for IVDs, including preparation of reports and interaction with regulatory officials.
  • Review product labelling and promotional literature for regulatory compliance.
  • Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.
  • Liaise with regulatory agencies for enquiries and issues.
  • Review R&D protocols and technical reports and other company documents for use in regulatory submissions and in response to questions from regulatory authorities.
  • Oversee and direct the preparation of regulatory documentation for country specific registrations.
  • Develop regulatory SOPs relevant for registration of IVD products or other regulatory aspects.

 

Person specification:

  • Extensive experience in the medical device industry, preferably with IVD experience and extensive regulatory affairs experience.
  • Experience in the preparation and submission of 510K, PMAs, IND, CE Design Dossiers, CE Technical Files.
  • Possess a working knowledge of MDD and IVDD, applicable ISO standards.
  • Ability to work as part of a team.
  • Excellent influencing and negotiating skills.
  • Excellent verbal and written communication skills.

 

How to apply:

For more information or to apply for this Associate Director of Regulatory Affairs position, please contact Meera on 01438 870024 or email a copy of your CV to mpattni@ckregulatory.com. Please quote reference CL22924 in all correspondence.