Regulatory Affairs Specialist – Consultant

Regulatory Affairs Specialist – Consultant ClinChoice 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.   Job Description Sr. Product License Maintenance Manager, (PLM) Compliance Support Location - Mexico (Remote) - Contract 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  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.