Regulatory Affairs Specialist – Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Specialist – Consultant (Sr. Product License Maintenance Manager, (PLM) Compliance Support) for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Responsibilities

• Accountable for reviewing new certificate requests and forwarding to relevant suppliers for processing
• Responsible for NDA Annual Report compilation and Drug Listing submissions to FDA

• Manages multiple tasks simultaneously to ensure performance metrics and filing deadlines are achieved according to agreed targets and BOH due dates.
• Liaise with where necessary to collect the information needed to submit the certificate request to the Contractor. If re- work is identified, track all rework through systems.
• Forward request to the identified Contractor for    processing,   within    the    timeframes identified by the relevant project team.
• If  required,  manage  legalization  through Consular     Services     ensuring     relevant administration,  fees   are   completed   and timelines adhered to.
• Communicate with requestor, Contractor or Consular   Service   to   ensure   request   is processed,    queries    are    answered    and timelines are met.
• Project       manage       multiple       requests simultaneously, ensuring filing deadlines are reached and next action dates are maintained in real time by pulling pending reports from systems.
• Escalate to Client and Contractor point of contact when timelines may not be reached.
• Maintain Clients systems and process throughout processing of request to ensure real time reflection of request is visible to all users.

• To seek approval from Clients end lead, should any certificates require fast tracking.
• Supports  delivery  of  electronic  and  paper regulatory transactions and electronic review aids  in  support  of  Drug  Listings,  Drug Establishment Registrations, And (A) NDA Annual Report submission to FDA
• Continuous     Improvement     of     selected processes     relating     to     human     health submissions and selected drug and non-drug specific projects and related activities e.g., Drug listing and Establishment registrations,
• Delivery  of  Product  License  Maintenance Portfolio in a timely and quality manner

Minimum Requirements

• 3+ years Regulatory experience
• Experience submitting US Annual Reports
• Demonstrated ability to support international product approval
• Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines.
• Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.
• Can demonstrate leadership and team skills.
• Advanced Microsoft Office Suite skills.
• Highly efficient communicator.
• Acts decisively and seizes accountability
• Bachelor’s degree Level (desirable or equivalent work experience.
• Familiarity with pharmaceutical organizational Structures.

Key words: PLM, Regulatory Affairs, Product License

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