Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

Senior Regulatory Affairs Manager

Posted Aug 17, 2020
Job ID: JJJP00003071
Location
High Wycombe
Duration
4 months
(Sep 7, 2020 - Dec 31, 2020)
Hours/week
37 hrs/week
Payrate range
60 - 75 £/hr

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting for Senior Regulatory Affairs Manager to join our contingent workforce.


Responsibilities:


  • Provide Regulatory support for promoted and non-promoted products
  • Prepares and submits regulatory documentation with support from RSMO as required
  • Monitors deadlines for different projects to ensure they are met or escalated to the Head of RA
  • Responsible for the content of the local labelling documents released to prescribers and patients
  • Prepares and distributes local labelling documents within stipulated timelines following receipt of relevant approvals from RRR
  • Prepares and manages local procedures following EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance
  • Partner with allocated CVT to provide RA expertise and support implements risk management plans and when required co-ordinates cross-functional team to implement/update Risk
  • Responsible for specific therapeutic area activities, questions & relations, including CVT attendance as required.
  • Occasional therapeutic area technical and administrative activities as required.
  • Contribute to shaping local regulatory strategy.
  • Departmental management and coaching of direct reports.
  • Leads the adoption and implementation of new systems and processes to streamline routine regulatory activities.
  • Collaborates with, and influences cross-functional colleagues to ensure efficiency gains and to support business continuity.
  • Represent the RA at the Management Review Meeting
  • Respond to ad hoc questions/requests from Janssen senior leadership, using business relevant language
  • Lead timely response to Regulatory Enforcement Action engaging cross-functionally where necessary
  • Provide Regulatory support for a portfolio of promoted and non-promoted products
  • Prepares and submits regulatory documentation as required.
  • Monitors deadlines for different cross-team projects to ensure they are met or escalated to Head of RA.
  • Responsible for the content of the local labelling documents released to prescribers and patients
  • Prepares and distributes local labelling documents within stipulated timelines following receipt of relevant approvals from RRR.
  • Prepares for and manages local procedures following the EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance and explaining RA strategy to CVT.
  • Implements Risk Management Plans and when required co-ordinates of cross functional team to implement/update Risk Management Educational Material.
  • Ensures compliance with all regulatory requirements for self and team
  • Develops and maintain in depth knowledge of regulations/legislation
  • Be up-to-date with and adapt early to local changes in the regulatory environment
  • Supports EMEA with collection of RA competitive intelligence as required
  • Supports other departments based on their needs (logistic, quality, medical, commercial) by providing documentation and information in response to requests.
  • Proactively shares key regulatory insights with CVT to help shape brand strategy.
  • Contacts local health authorities to resolve queries (general or product specific) when these cannot be addresses internally contributing to positive relationship in any communication
  • Supports and contribute to GRA-EMEA initiatives as requested by Head of RA.
  • Contributes to local initiatives around lessons learnt and change management to ensure efficiency gains.


Experience and Key Competencies:


  • Significant Regulatory Affairs experience at both operational and strategic level.
  • Strong data gathering and analytical skills.
  • Direct experience and strong knowledge of general regulatory requirements and guidelines.
  • Significant persuading/ influencing, negotiating skills.
  • Significant line management experience.

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