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. **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 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 #LI-PB1 #LI-Remote