Regulatory and Scientific Affairs, Director

Feb 17, 2017

 

Our client is a leading biopharmaceutical company, founded by a group of institutional investors. Due to strategic growth, the company is looking to hire two new roles for its Bermuda operations: Quality Assurance, Director; and Regulatory and Scientific Affairs, Director.

The company has certain flexibility as to the number of years’ professional experience that candidates may have. As a result, we would be pleased to actively consider suitably qualified candidates whose experience may exceed, or not yet meet, the years indicated below.

Role and Key Responsibilities will include the following:

  • Interpret regulatory requirements, conduct assessments and develop strategies/contingencies for the preparation of regulatory submissions;
  • Prepare correspondence to global regulatory agencies and governing bodies;
  • Operate independently to resolve complex issues and manage regulatory risk, working in conjunction with the project team;
  • Create / contribute to the development of internal policies, processes and procedures to support the compliance of the company’s product lines;
  • Collaborate with contractors, vendors, and internal stakeholders to ensure compliance and execution of the company’s policies and strategies;
  • Support IND submissions through document and application preparation.

Skills and Qualifications:

  • Education Minimum Requirement: Graduate degree in scientific area required.
  • A minimum of 10 - 15 years’ experience in the Pharmaceutical industry in Regulatory and Scientific Affairs with broad functional knowledge of pharmaceutical sciences
  • Technical and scientific understanding of drug development with appropriate level of experience and skills in technical writing.
  • In depth knowledge of FDA regulatory requirements;
  • Excellent written and oral communication skills.

This is an outstanding opportunity to join the growing, biopharmaceutical sector in Bermuda and to develop your career in an innovative and dynamic environment.

Please forward a detailed resume and covering letter to: Alistair McNeish, PwC Human Capital Consulting Ltd., bermudatopjobs@bm.pwc.com


 

For further information on this job contact us at bermudatopjobs@bm.pwc.com

Please forward a detailed resume and covering letter to: Alistair McNeish, PwC Human Capital Consulting Ltd., bermudatopjobs@bm.pwc.com 


 

For further information on this job contact us at bermudatopjobs@bm.pwc.com

Please forward a detailed resume and covering letter to: Alistair McNeish, PwC Human Capital Consulting Ltd., bermudatopjobs@bm.pwc.com 


 

For further information on this job contact us at bermudatopjobs@bm.pwc.com

Please forward a detailed resume and covering letter to: Alistair McNeish, PwC Human Capital Consulting Ltd., bermudatopjobs@bm.pwc.com 

For further information on this job contact us at bermudatopjobs@bm.pwc.com

 

Contact us

Alistair McNeish
Director, Human Resource Services
Tel: +1 441 298 9708
Email

Linda Holmes
Human capital consulting
Tel: +1 441 298 9706
Email

Lyndsay McCabe
Client Administrator
Tel: +1 441 298 9705
Email

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