Regulatory Affairs Manager
- Recruiter
- Key People
- Location
- Uxbridge
- Salary
- Competitive
- Posted
- 25 Oct 2018
- Closes
- 22 Nov 2018
- Sectors
- Engineering, Defence
- Contract Type
- Permanent
- Hours
- Full Time
Job Description Responsibilities:
Strategy and Execution
* Plans and manage regulatory submissions for products within the company portfolio in compliance with global filing plans and local regulatory requirements.
* Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
* Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
* Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
* Supports regional label negotiation activities
* Participate in the development, and execution of regional regulatory product strategies
* Ensure regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders
* Communicates regulatory strategies within team
Basic qualifications:
* Scientific Degree and demonstrated experience in a similar role
* Regulatory principles
o Working with policies, procedures and SOP's
o Knowledge of legislation and regulations relating to medicinal products
o Awareness of the registration procedures in region for development, MA, post approval changes, extensions and renewals.
* Knowledge of drug development
* Knowledge of and experience in regional regulatory environment
* Team work
* Communication skills - both oral and written
* Ability to understand and communicate scientific/clinical information
* Ability to anticipate and prevent potential issues
* Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
For further details about this role, or other opportunities within Regulatory Affairs, please contact Tim Barratt on (0) or email
Strategy and Execution
* Plans and manage regulatory submissions for products within the company portfolio in compliance with global filing plans and local regulatory requirements.
* Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
* Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
* Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
* Supports regional label negotiation activities
* Participate in the development, and execution of regional regulatory product strategies
* Ensure regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders
* Communicates regulatory strategies within team
Basic qualifications:
* Scientific Degree and demonstrated experience in a similar role
* Regulatory principles
o Working with policies, procedures and SOP's
o Knowledge of legislation and regulations relating to medicinal products
o Awareness of the registration procedures in region for development, MA, post approval changes, extensions and renewals.
* Knowledge of drug development
* Knowledge of and experience in regional regulatory environment
* Team work
* Communication skills - both oral and written
* Ability to understand and communicate scientific/clinical information
* Ability to anticipate and prevent potential issues
* Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
For further details about this role, or other opportunities within Regulatory Affairs, please contact Tim Barratt on (0) or email