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