Posts Tagged ‘Regulatory Affairs’

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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Keep track of Regulatory Affairs events with the new smart phone app

Monday, November 14th, 2011

The Organisation for Professionals in Regulatory Affairs (TOPRA) has developed both an iPhone and Android app to help professionals working in reg affairs to keep up-to-date with their events.

With one click of a button, you can add any event to your calendar and visit the TOPRA website for more information.

TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Their current membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.

To download the app from  iTunes, please click here.

Global Regulatory Affairs CMC Associate Job in Yorkshire, UK

Monday, October 3rd, 2011

Meera Pattni at CK Clinical is recruiting for a Global Regulatory Affairs CMC Associate to join a successful and innovative pharmaceutical company at their site in Yorkshire, UK.

 

The job:

As Global Regulatory Affairs CMC Associate, you will be required to assist the new product development and existing product development projects within the scope of the global regulatory CMC team. You will also assist and support regulatory CMC strategy and deliver submissions.

Responsibilities:

  • Deliver global regulatory affairs CMC project activities by effective coordinator, strategy and implementation.
  • Prepare and deliver regulatory submissions including CTAs, MAAs, INDs and variations/renewals in line with defined CMC plans.
  • Work collaboratively with appropriate company personnel and contractors to coordinate the regulatory work stream elements for CMC activities.
  • Liaise with regulatory authorities as required.
  • Maintain documented regulatory project plans in line with best practice recommendations.
  • Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the CMC team.

 

The ideal candidate:

Meera is looking for candidates will the following skills:

  • Excellent communication skills.
  • Highly organised.
  • Ability to handle multiple projects at once.
  • Results orientated.
  • Strong negotiating and interpersonal skills.
  • Openness to change.

 

How to apply:

For more information or to apply, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22877 in all correspondence.

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Senior Regulatory Engineer Job in the Netherlands

Tuesday, August 30th, 2011

Meera Pattni at CK Regulatory is recruiting for a Senior Regulatory Engineer to be based in the Netherlands.

The Company

Meera’s client is a global marketer of consumer and commercial products that develop innovative products and system solutions in the categories of food service, cleaning, safety, material handling, refuse and agriculture amongst others.

The Job

As Senior Regulatory Engineer, you will be responsible for coordinating and auctioning activities within regulatory affairs to ensure that all manufactured products and services provided by the company meet the quality requirements of the company, regulatory and notified bodies.

Responsibilities:

  • Manage the regulatory affairs area to ensure that objectives are implemented in line with overall quality/corporate goals.
  • Ensure compliance with local regulatory agencies and establish relationships with outside testing facilities as required.
  • Provide update regarding regulatory status and requirements of company products. Ensure customers receive regulatory and certification information in a timely manner.
  • Compile device master records, technical files, design dossiers, FDA and European submission documents that meet regulatory requirements.
  • Ensure staff understand and comply with the requirements of cGMP as applied to the company products.
  • Review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements.
  • Participate in the development and maintenance of the Company’s Quality System to meet the requirements of the US FDA and other applicable quality and regulatory standards.

 

You:

The ideal candidate for this Senior Regulatory Engineer will have the following skills and experience:

  • Degree in a science or quality related subject.
  • Previous experience in a quality or regulatory affairs role essential.
  • Experience in the development and management of regulatory submissions and documents.
  • Experience with internal and external audit processes.
  • Demonstrated expertise in cGMPs, FDA regulations, SOP development.

 

Apply now:

For more information or to apply online for this Senior Regulatory Engineer position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com. Please quote reference CL22593 in all correspondence.

Regulatory Affairs Manager Job – Kent

Monday, August 15th, 2011

Meera at CK Regulatory is recruiting for a Regulatory Affairs Manager to join a food company based in Kent, UK.

The job:

As Regulatory Affairs Manager, you will be required to support the Marketing, Sales, Innovation and Technical Teams in ensuring all product labels meet legal requirements in all countries the products are sold. You will also be responsible for ensuring that all nutritional information is accurate and legal.

Main responsibilities:

  • Responsibility for all food safety and food quality legislation in all countries.
  • Responsible for all product labelling and nutritional labelling for the business.
  • Approval of any on pack health or nutrition claims.
  • Liaison with EHO, TSO, FSA and other similar bodies relating to UK and EU targets relating to food safety, quality, nutrition and labelling.
  • Management of salt, fat and other key parameters to ensure compliance with UK and EU requirements.
  • Keeping abreast of legislative changes and ensuring the business understands key changes to legislation and implement changes accurately.
  • Develop and support the Process Development Teams to ensure they can support the Regulatory Affairs Manager.
  • Develop a strong network with the required agencies.
  • Management and resolution of any issues relating to labelling, and nutrition.

 

Person specification:

The successful candidate for this Regulatory Affairs Manager position will have the following qualifications, skills and experience:

  • Degree in food related subject.
  • Experience in a legislation, labelling, and nutrition role within the food industry.
  • Experience dealing with regulatory agencies.
  • Working knowledge of the Global Standard for Food Safety.
  • Working knowledge of HACCP.
  • Excellent communication skills.

 

How to apply:

For more information or to apply for this Regulatory Affairs Manager position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.

Regulatory Affairs Therapy Area Head Job – Berkshire, UK

Monday, August 8th, 2011

Meera Pattni at CK Regulatory is looking for a Regulatory Affairs Therapy Area Head to join a large Pharmaceutical company based in Berkshire.

The role:

As Regulatory Affairs Therapy Area Head, you will work within Immunology, Virology, Neonataology and Oncology. CNS/Pain groups. Your main responsibilities will include:

  • You will be responsible for setting and implementing regulatory strategy for the assigned therapeutic area.
  • Represent Regulatory Affairs on Brand Teams.
  • Lead and support regulatory personnel in the affiliate groups, through ongoing communication and development, as well as training and mentoring of local Regulatory Leaders.

 

The ideal candidate:

To be considered for this position, you will have the following skills, qualifications and experience:

  • Previous experience in a Senior level regulatory position within the pharmaceutical industry.
  • Excellent understanding of the regulatory requirements for the Western Europe and Central/Eastern Europe and Russia regions.
  • Existing network of regulatory authority contacts in the relevant markets.
  • Excellent communication skills, knowledge of a second language would be an advantage.
  • Previous experience developing regulatory strategy required.

 

How to apply:

For more information or to apply for this Regulatory Affairs Therapy Head, please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com.

Nektar Given Good News on Cancer Drug

Tuesday, July 19th, 2011

Nektar has been given a positive review of its ovarian cancer drug, reports the Pharmaceutical Business Review.

The Committee for Orphan Medicinal Products, a branch of the European Medical Association, has responded positively in relation to Nektar’s attempt to have its ovarian cancer drug granted orphan medicinal product status, which can lead to extended exclusivity. A phase II study is currently recruiting patients with ovarian cancer, whilst the company are looking to begin a phase III study later this year.

Nektar Drug Development and Regulatory Affairs vice president Carlo DiFonzo has said that the news of the positive opinion is welcome following the recent designation of orphan drug status in the US in April.

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