Interim Consultant Reg Affairs – £275-£300 a day – 6 months

Pay & benefits:
£275 - £300 per day

Duration:
6 months

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Interim Consultant Reg Affairs – £275-£300 a day – 6 months

Interim Consultant Regulatory Affairs – £275-£300 a day – 6 months – Middlesex

A large Bio-Pharma company are looking for an Interim Associate Manager for Regulatory Affairs for the Rest of the World (ROW) markets.
The Consultant will sit in the ROW Markets Team, which provides regulatory support to the clients activities in markets outside of the EU/US; more specifically within the Asia Commercial.
The short term objectives of this role are to maintain existing licenses in the Asia Commercial region, and support new licence applications in line with commercial priorities.

Interim Consultant Regulatory Affairs – £275-£300 a day – 6 months – Middlesex

Responsibilities of the role:

  • Preparation and/or coordination of designated regulatory submissions for clients marketed products in the Asia Commercial region, in line with corporate objectives. These submissions may include, but are not restricted to, new license applications, renewals, labelling updates and variations.
  • Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
  • Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling for new MAAs or variations affecting the labelling, and in line with required timelines, for products registered in the Asia commercial region.
  • Liaises directly with local Affiliates, distributors or agents to define/clarify submission requirements, and follow up on submissions, requests for supplementary information and approvals with specific country and/or regional responsibility within Asia Commercial region.

Interim Consultant Regulatory Affairs – £275-£300 a day – 6 months – Middlesex

Key skills and experience required:

  • Life Science degree.
  • 5+ years of experience in Regulatory Affairs. Direct regulatory experience with ROW markets is desirable.
  • A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other functions.
  • Direct experience in regulatory submissions across ROW markets is highly desirable.
  • In depth knowledge of regulatory requirements, including ICH requirements and regional requirements. Also is developing an appreciation of current global and regional trends in Regulatory Affairs.
  • Excellent organisational skills and ability to work on a number of projects with tight timelines.
  • Excellent influencing / negotiation skills, with strong communication skills both in writing and verbally
  • Methodical attention to detail
  • Must have a “can do” attitude and be “hands on” as and when required

Interim Consultant Regulatory Affairs – £275-£300 a day – 6 months – Middlesex

Oasis HR is committed to equal opportunities for all, irrespective of age, religion or sexual orientation, ethnic or national origin, gender, race, disability and in line with the 2010 Equalities Act. Our commitment is based on strong ethical beliefs because we value a diverse customer base & the individualism each employee brings to our business.

Equal opportunity is about good, fair employment practices which make sound business sense. Every person has the right to work and do business in an environment free of discrimination and harassment. For more information on our equal opportunities and diversity values please contact us.

By applying for this job you acknowledge and approve that your information may be processed by any Oasis HR Recruitment Consultant for the purpose of evaluating your application for employment and performing any related activities. By submitting your application, you also acknowledge and approve that your information may be stored in Oasis HR’s Application Tracking System and might be used to consider you for future potential opportunities with our clients. Your information will be accessible by Oasis HR’s Recruitment Consultants and other relevant support teams; such as Finance / Accounts and Marketing. You may at any time withdraw from a particular vacancy for which you may be applying by contacting the Recruitment Consultant managing the search, by emailing info@oasishr.comor by telephoning 0207 11 88 444. If you wish to obtain additional contact details regarding your data controller/holder, or receive a copy of your personal information that we keep, or if you would like to update or delete your details, please contact us.

Oasis HR are a multi-award winning specialist supplier of HR and Talent Management Professionals. We provide permanent, contract and interim professionals to the private and public sector, dealing with a wide range of assignments. We are acting as a Recruitment Agency in relation to this role.

Job Reference: JO-1808-31371533893427

Salary From:

Salary To:

Day Rate From: 275

Day Rate To: 300

Salary per: Day

Job Duration: 6 months

Job Start Date: ASAP

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Oasis HR is committed to equal opportunities for all, irrespective of age, religion or sexual orientation, ethnic or national origin, gender, race, disability and in line with the 2010 Equalities Act. Our commitment is based on strong ethical beliefs because we value a diverse customer base and the individualism each employee brings to our business.

Equal opportunity is about good, fair employment practices which make sound business sense. Every person has the right to work and do business in an environment free of discrimination and harassment. For more information on our equal opportunities and diversity values please contact us.

By applying for this job you acknowledge and approve that your information may be processed by any Oasis HR Recruitment Consultant for the purpose of evaluating your application for employment and performing any related activities. By submitting your application, you also acknowledge and approve that your information may be stored in Oasis HR’s Application Tracking System and might be used to consider you for future potential opportunities with our clients. Your information will be accessible by Oasis HR’s Recruitment Consultants and other relevant support teams; such as Finance / Accounts and Marketing. You may at any time withdraw from a particular vacancy for which you may be applying by contacting the Recruitment Consultant managing the search, by emailing info@oasishr.com or by telephoning 0207 11 88 444. If you wish to obtain additional contact details regarding your data controller/holder, or receive a copy of your personal information that we keep, or if you would like to update or delete your details, please contact us.

Oasis HR are a multi-award winning specialist supplier of HR and Talent Management Professionals. We provide permanent, contract and interim professionals to the private and public sector, dealing with a wide range of assignments.

We are acting as a Recruitment Agency in relation to this role.

Oasis HR is committed to equal opportunities for all, irrespective of age, religion or sexual orientation, ethnic or national origin, gender, race, disability and in line with the 2010 Equalities Act.

Our commitment is based on strong ethical beliefs because we value a diverse customer base & the individualism each employee brings to our business.

Equal opportunity is about good, fair employment practices which make sound business sense. Every person has the right to work and do business in an environment free of discrimination and harassment. For more information on our equal opportunities and diversity values please contact us.

Oasis HR are a multi-award winning specialist supplier of HR and Talent Management Professionals. We provide permanent, contract and interim professionals to the private and public sector, dealing with a wide range of assignments.

We are acting as an Employment Business in relation to this role.