Senior Regulatory Operations Manager - Barcelona, Spain

Company
Synteract
Location
Spain
Salary
Competitive
Posted
27 Apr 2021
Closes
27 May 2021
Ref
29062
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Regulatory Operations Manager - Europe- Remote Based

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

The Senior Regulatory Operations Manager works closely with Regulatory Operations Department Management assuming a leadership role
in the research, development.

Specific tasks would include:

  • Act as Regulatory Country Expert and compiles submission packages and dossiers and reviews all documents required for submissions to ECs (ex-US), and Regulatory Authorities.
  • Serves as interface between regulatory authorities, ECs (ex-US) and the Regulatory Lead
  • Ensures that clinical trials applications (CTAs) are conducted according to local/international requirements/procedures (e.g.,
  • ICH-GCP and applicable local law, guidelines, and internal procedures).
  • Prepares National Informed Consent Forms, and performs lay language review
  • Ensures compliance with Regulatory Agency rules and guidelines pertaining to regulatory submissions (paper and electronic).
  • Anticipates areas with the potential to jeopardize regulatory timelines and identifies solutions.
  • Assists in the management of established timelines to achieve client deliverables on time/within budget.
  • Attends project team meetings, if needed.
  • Assists the pharmacovigilance team with safety reporting, if required
  • May serve also as Regulatory Lead for multinational clinical trials and coordinates submissions for those projects
  • As regulatory lead be the primary regulatory contact for clients
  • Is responsible for managing regulatory timelines and resources for the studies assigned to achieve client deliverables on time and within budget.
  • Contributes to the company's Regulatory Intelligence database and supports the Regulatory Intelligence Officer, as needed.
  • Helps prepare for, and participates in, client and regulatory authority audits and inspections.
  • May perform QC review of any regulatory / submission documents.
  • Supports business development in preparing and defending requests for proposals.
  • Reviews, revises, and writes department procedures, as needed
  • Serves as Regulatory Lead for larger, complex, global clinical trials without acting as Regulatory Country Expert and performing associated national submissions
  • Assumes a leadership role in the regulatory operations department, guides regulatory operations team members and acts a role model for department members


Qualifications

  • Bachelor's degree in business, life sciences or related field of study and 8+ years Regulatory Operations experience in the pharmaceutical industry / Clinical Research Organization, or equivalent combination of studies and relevant work experience inclusive of substantial experience in researching, reviewing, and processing regulated documents and the demonstrated ability to provide guidance and direction to others effectively
  • Advanced knowledge base of global regulation of investigational and marketed medicinal products including international and national regulations and guidelines, depending on regional responsibility (e.g. European, US and Canadian regulations/guidelines).
  • Ability to evaluate regulations and electronic processes and requirements.
  • Proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook.
  • Highly effective verbal and writing skills; English + knowledge of local language is mandatory for submissions/correspondence
    with authorities and Ethics Committees. Proficiency in secondary language desirable.


If you're passionate about clinical trials, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, colour, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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