Regulatory Affairs Manager

  • Location:

    Hayes, London

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    £50 - £65 per hour

  • Job ref:

    BBBH103579_1558104401

  • Published:

    7 days ago

  • Duration:

    6 Months

  • Client:

    Undisclosed Company


Senior Manager, Regulatory Affairs - £50/£65 p/h - 6 months

The work location is based in Stockley Park on 6-months contact duration
Pay rate is between £50 - £65 per hour.

Description:
* Bachelor's degree in scientific discipline or equivalent
* European regulatory experience required
* Experience in Haematology/Oncology or Inflammation/Immunology drug development preferred
Contributes to the development, execution & delivery of EU regulatory strategy for assigned projects. Responsible for the building of regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. Liaises with Regulatory Affairs (RA) Franchise Team management & with other internal/external stakeholders. May be responsible for managing & developing staff.

Responsibilities will include, but are not limited to, the following
* Contributes to the development of EU regulatory product strategy based on strategic imperatives, product knowledge, global and regional regulatory requirements, including assessment and inclusion of innovative regulatory pathways to achieve regulatory approvals meeting business needs.
* Works with Regulatory Franchise Team Leadership to ensure that EU regulatory product strategy and deliverable are developed in alignment with Global Regulatory Affairs (GRA) and the Global Project Team (GPT).
* Maintains awareness of emerging issues that may impact regulatory product strategy and EU regional business. Proposes adjustment of the strategy and implementation plan in response to new information or changes in the competitive landscape and consults with management..
* Maintains knowledge of current EU regulatory guidance and procedures and reviews new guidance for impact on regulatory product strategy and discusses with management.
* Works with Regulatory Franchise Team Leadership to ensure that product development programs and life-cycle plans are aligned with strategic oversight, business model, Global and EU regulatory requirements.
* May have global responsibility for specific projects which will require; a knowledge of global regulatory requirements, development and ownership of the Regulatory Development Plan (RDP), responsibility for Worldwide submission plans and accountability for global regulatory documents such as clinical trial/marketing applications and for interactions with global Health Authorities.
* Responsible for or contributes to the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of licences for products assigned.
* Supports or may be responsible for ensuring that fulfils Health Authority commitments.
* May represent RA at Governance Committees
* May be responsible for ensuring that GRA, GPT, RA EMEA Labelling, Regulatory Operations and Affiliate Regulatory are kept updated in a timely manner, on regulatory product plans, progress and operational issues
* Reviews draft protocols, acts as Regulatory Franchise Team representative in clinical study teams and liaises with the individuals with CTA or CRO oversight responsibility.
* Acts as Subject Matter Expert on designated studies in the event of the Health Authority Inspection
* Responsible for the delivery of Content Plans to allow publishing and timely dossier submission
* Responsible for tracking and communicating regulatory activities within RA and for ensuring that submission plans are captured accurately.
* Monitors resource needs through discussion with manager.
* May contribute to planning and monitoring the budget for the assigned projects.
* Identifies any learning or best practice within RA EMEA group and communicates to manager.
* May participate in cross-functional initiatives.
* International travel may be necessary.

Key Requirements/Knowledge
* Bachelor's degree in scientific discipline or equivalent required.
* Experience in EU Regulatory Affairs & recent experience of EU Centralised Procedure required.
* In-depth knowledge of current EU regulatory requirements essential
* In-depth understanding of CTD modules; non-clinical, CMC, Clinical
* Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
* Knowledge of Therapeutic area for assigned projects
* Experience of leading projects through Regulatory Procedures
* Experience in Haematology/ Oncology or Inflammation/ Immunology preferred
* Experience of contributing to Ph III protocols & able to contribute to clinical development plans.

Competencies/Skills
* Actively engages in professional development
* Seeks opportunities to learn from others
* Effective project manager, developing leader. Creates project plans, prioritises effectively, leads teams in project execution & delivery
* Ability to lead complex regulatory submissions. Leads activities for assigned projects
* Demonstrates appropriate decision making
* Conveys trust in others knowledge, skills & judgement & provides team members with appropriate levels of autonomy & decision-making authority.
* Acknowledges others who take the initiative to try new approaches even if the results are not perfect

If you are relevant or interested don't delay, contact me on 0161 924 1400 or email me at

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