An internationally known biotechnology company has an opening for a Senior Regulatory Consultant job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.
Responsible for supporting the development and implementation of innovative global regulatory strategies for new products in specific markets. Global responsibility for 1 or more product assets. Responsible for the development , communication, support and implementation of lifecycle management strategies primarily in the safety/clinical space. Ensuring availability of submissions documentation and their subsequent control.
Principal Accountabilities for this role include:
Responsible for the successful development and implementation of regulatory strategies for new submissions including post-approval compliance for in region/markets of responsibility.
- To provide support for Regional Regulatory Leads - responsible for new submission planning, strategy and implementation.
- Provide strategic guidance and regulatory leadership at project team meetings as well as represent the Global Emerging Markets strategy for assigned products in region.
- Identify and assess regulatory risks associated with the execution of regulatory strategies in assigned region/ markets. Define strategies to mitigate risks.
- Keep abreast of changes in regional legislation.
- Responsible for coordinating the preparation of the regulatory submissions and coordinating responses to questions from the Health Authorities
- Highlight key issues that may impact the execution of regulatory strategy across territories.
- Build and maintain effective relationships with both internal as well as external stake holders
- Prepare and deliver effective presentations for external and internal audience
- Demonstrate strong organizational skills, including the ability to prioritize personal and any direct reports workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, drug safety, scientific, and manufacturing staff.
Qualifications required for the role:
Minimum 4-5 Regulatory Experience preferably in the Emerging Markets sphere
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Elise Lambeth on +44 207 4400 633 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.