SRG Clinical

Regulatory Affairs Manager- CTA- EU- 28291

Location
Uxbridge
Salary
Negotiable
Posted
27 Nov 2018
Closes
25 Dec 2018
Ref
J29502
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Consultant on an initial 6 Month basis to be based at their offices in Cambridge or Uxbridge.

The Role:

Maintain all the required licenses in order to support clinical trials and further development of IMPD’s; market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety.

Key Responsibilities:

• Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Provides 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
• Under general supervision participate in the development, and execution of regional regulatory product strategies
• Ensures regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders
• Communicates regulatory strategies within team
• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
• Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to marketed products.
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product development.

Skills/Experience Required:

Education

* Life Sciences Degree qualified.

Knowledge

* Extensive hands on experience within Regulatory Development.
* Awareness of registration procedures within the EU including MA’s, Post Approval changes, line extensions and renewals.
* Hands on experience with policies and implementation of SOPs’

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

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