Senior Regulatory Affairs Manager

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.