Science, Pharmaceutical & Food

Senior Manager Regulatory Affairs

Posted 5 months ago
Contract
London City, London, UK
41987496

PE Global is currently recruiting for a Senior Manager Regulatory Affairs for an initial 12 month contract role with a leading multinational Biotech client based in London.

For one or more orphan product licences, the EU lead will perform a range of responsibilities depending upon the product lifecycle stage. The EU lead should work with their manager and the GRL and/or global clinical/non-clinical staff to clearly define roles/responsibilities for specific product activities and deliverables between EU Reg and Global Clin/Non-clin teams.

We are looking for candidates with 5-10 year EU Centralised regulatory experience, preferably in orphan medicines.

Job Responsibilities

Regulatory Strategy Development

Develop, execute on and maintain the EU aspects of the clinical and non-clinical regulatory strategy of the Global Regulatory Plan (GRP) throughout the product lifecycle, in collaboration with the GRL ensure the needs of the EU for the clinical and non-clinical development plans (and risk/mitigation of any gaps) are appropriately integrated into the GRP.
Collaborate with the GRL to ensure that EMA/NCA feedback/scientific advice is appropriately incorporated into the GRP/global clinical/nonclinical development plans, and that risks/mitigations of not following advice provided by EU HA’s are captured and communicated.
Collaborate with the GRL, and cross-functional SME’s as appropriate, to maintain an EU Paediatric Investigation Plan (PIP) strategy and ensure that the needs of the EU PIP are appropriately reflected in the global paediatric regulatory strategy in the GRP. Maintain agreed PIP and assess any proposed changes to the CDP/study designs, and non-clinical development plans for impact to agreed PIP.

Clinical and Nonclinical Development Plan Advancement

Contribute to the Clinical and Nonclinical Development Plans in collaboration with the GRL to ensure that they incorporate consideration of EU health authority precedents and regulatory guidance.
Provide EU strategic input and regulatory expertise to the GRL in the design and conduct of clinical and nonclinical studies.
Contribute critically to the interpretation of emerging clinical/non-clinical data from an EU perspective.

Health Authority Interactions

Act as the point of contact for EMA/NCA throughout lifecycle management.
Lead planning and preparation for EMA/NCA meetings, working closely with Subject Matter Experts (SMEs) and the GRL to define content that is optimal for the EMA/NCA.
Lead EMA/NCA interactions in alignment with corporate and/or program goals.
Serve as the point of contact for EMA/NCA regarding nonclinical/clinical communications.
Through the GRL ensure that EMA/NCA feedback is incorporated into the clinical and nonclinical aspects of programs.
Lead development of the EU submissions.

Regulatory Submissions and related activities

Broadly, ensure that the clinical and nonclinical content is adequately presented in EMA/NCA submissions leading to successful approvals.

CTAs:

Advise global team on core clinical and nonclinical content for EU NCA clinical trial applications via the CTR &/or national procedures.
Act as regulatory liaison with study CRO’s to oversee, support and maintain EU clinical trials applications, act as liaison directly with NCA as appropriate (e.g., MHRA).
Partner with global regulatory representatives to confirm CTA requirements as needed.
Ensure transparency and reporting requirements for clinical trials in Europe are understood within BMRN.

UK/CH Marketing Applications (MAs):

Serve as EU lead on MA Filing Team to support MA preparation, submission, review through to approvals.
Provide oversight of CROs/vendors that are contracted to perform any of the regulatory activities related to EMA/NCA regulatory submissions.
Work with GRT and Market Timing to define content/timing for any CH or UK marketing applications.
Collaborate with GRL and SMEs to determine strategy for responses, authoring of responses, and review of responses drafted by SMEs.
Collaborate with labeling to support nonclinical / clinical Labeling content negotiations with UK/CH.

Commercial Stage Products require the EU lead to have the following responsibilities

Maintenance

Primary liaison with regional NCA’s for given product for questions, negotiations around regulatory and supply chain.
Support for ongoing and new CTAs as defined above, via the CTR & or national procedures.
Work with NCA’s to define local regulatory requirements for launch and commercialization (e.g. NCA review of additional Risk Minimization Measures (aRMMs)) and ensure timely submissions and approvals to support country launch plans.
Lead activities related to regulatory compliance and transparency, e.g. EMA Policy 0070 and 0043, EudraCT postings, sunset clause, Annual Reports/Annual Re-Assessment Reports.
Continue to represent EU regulatory on e.g. the CDT, SET, MAPT, Core Team/IBT as required.
Ensure fulfillment and reporting of EU clinical Specific Obligations/Commitments, Post Approval Measures, including timely and effective communication of HA feedback (post-marketing study expectations and commitments/milestones) to relevant partner teams and the GRT.
Co-ordinate submission of clinical related variations to the EU MA.
Lead submission of post-approval reports including annual reports for Conditional Marketing Authorisations (CMAs), Exceptional Circumstances Marketing Authorisations (ECMAs), PIPs, and required submissions such as PBRERs.
Provide oversight of CROs/vendors that are contracted to perform any of the regulatory activities related to regulatory submissions and HA interactions.
May act as adviser/consultant to INTL teams that reference the EU submission/approval as required on relevant aspects of the EU MA review, post approval activities.