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Regulatory Compliance Lead / QMS Manager

Ref: : 21641500 (Lilium Direct Ltd)
Location: :

Harlow - London

Rate: £ Attractive (Permanent) + D.O.E
Industries: Biotechnology / Pharmaceutical
Functional Areas: Consulting

Regulatory Compliance Lead / QMS Manager

Our Client are looking for a Regulatory Compliance Lead / QMS Manager to join their team based in Harlow.

The QMS Manager implements quality principles and mindsets across the Regulatory Affairs function in line with legislative and Regulatory expectations; driving compliance across related activities.

They will train members of the team and collaborate with functional group heads to ensure timely and effective communication, including escalation of any concerns to other members of the Senior Management team.

The QMS Manager will be expected to lead by example, being professional and diligent. They will be responsible for reporting back as needed to the cross-functional Senior Management Team.

Working in a consultancy is a demanding and rewarding role where no two days are the same and as such the applicant should be flexible, willing to work under pressure and able to provide assistance to other team members to ensure the company delivers against its objectives.



General Responsibilities and Duties of the Dept:

The function provides end to end regulatory services and expertise driven product development advice from early stages of development through to post market support. The regulatory division are experts in all aspects of European regulatory affairs providing support to clients in the following areas:

* Writing product development plans and providing gap analysis
* IMPD/IND writing
* Technical CMC support
* Preparing orphan applications, PIPs and PRIME submissions
* Assisting with scientific advice procedures
* Clinical Trial Application submissions
* GMO applications
* Ethics submissions
* Assistance in preparing and submitting variations and Marketing Authorisation
* Applications through the various Regulatory Authority procedures
* Acting as an overflow Regulatory Department



Key Responsibilities and Duties of the Role:

* Develop and implement the processes and systems necessary to ensure that the organisation will meet both the current and future legislation requirements associated with providing a compliant Regulatory service.
* Embed and maintain a quality culture within the department.
* Ensure consistent quality and standards are upheld within the Regulatory department.
* Evolve and maintain the Regulatory change management process.
* QMS Owner - perform periodic reviews and maintain oversight of the organisations QMS.
* Prepare, lead and support regulatory inspections and vendor audits
* To lead the quality function by helping to identify, and oversee the process for handling change, non-conformities, breaches, complaints and ensuring appropriate corrective and preventative actions.
* To perform impact assessment for all investigations and to establish plans for continual improvement of the QMS and related compliance programmes.
* Establish and maintain the companies Business Continuity Plan (BCP).
* Lead the implementation of the Gener


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