Mgr, CMC Regulatory Consulting - experience in Biologics is required
Syneos Health
Based, Home, PRT, Portugal
há 3 dias

JOB SUMMARY

Responsible for management and development of CMC Regulatory Consulting staff as required. Interacts with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance.

Directs and oversees CMC regulatory aspects of EU-based product development including, but not limited to : advising clients on CMC regulatory requirements in Europe, preparing and reviewing regulatory submissions (such as IMPDs, MAAs, meeting packages, etc.

reviewing client regulatory documents, assisting senior management with administration of the Regulatory Affairs Department, developing work flow, and regulatory records document processes.

JOB RESPONSIBILITIES

  • Provides strategic and tactical CMC regulatory guidance relating to global drug development, serving as Subject Matter Expert for EU-based regulatory submissions and key point of contact for Syneos clients and for internal Syneos teams.
  • Authors Chemistry, Manufacturing and Controls (CMC) sections of regulatory documents from source documents provided by the client, such as regulatory meeting briefing documents, module 2 sections, module 3 sections, and other relevant modules of regulatory applications that are acceptable to regulatory authorities.
  • Reviews customer documentation and / or regulatory dossiers for completeness and compliance with regulatory requirements and communicates assessment outcomes with clients.
  • Contributes to, and reports on client and regulatory agency meetings, as needed. Provides CMC RA expertise to clients in compiling regulatory submission documents.
  • Leads CMC-specific discussions with EU regulatory authorities as needed on behalf of Syneos clients.

  • Manages timelines and resources for CMC aspects of regulatory submission projects to meet client’s expectations. Interacts professionally at multiple levels within a client organization to communicate recommendations, obtain necessary information, provide status or updates to project deliverables.
  • Provides timely, accurate support to business management staff regarding hours to be budgeted for assigned regulatory tasks for Requests-for-Proposal (RFP).
  • Supports business development, including generation of repeat business from existing clients and proposal development

  • Ensures Standard Operating Procedures are followed for adequate completion of regulatory documents.
  • Contributes to process improvement and experience sharing efforts within Global Regulatory Consulting (GRC).
  • Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
  • Line management responsibilities for staff members as assigned. For direct and indirect reports, may participate in and manage activities related to department staff operations.
  • Qualifications

    QUALIFICATION REQUIREMENTS (please indicate if preferred’)

    Along with demonstrated initiative, uncompromising integrity and a results-oriented mindset, the ideal candidate has :

  • MS degree or above, preferably in a science-related field or equivalent with at least 5-10 years’ experience in science / regulatory-related field.
  • Demonstrated pharmaceutical / biologic / medical device related experience and comprehensive understanding of pharmaceutical and / or medical device product development.
  • Experience working with small molecule and biologic drug products is desired.

  • Demonstrated experience in CMC regulatory affairs in the EU, including but not limited to knowledge and application of relevant statutes, regulations and guidance, and product and process analytics, specifications, comparability, and stability.
  • Experience leading, facilitating or contributing to meetings with EU regulatory authorities desired.
  • Demonstrated experience in contributing to the preparation of regulatory submissions including, for example, Scientific Advice briefing packages, IMPD, MAA, variations, etc.
  • Experience in other regulatory markets is a plus.

  • Excellent customer service and interpersonal skills, with the ability to work both independently as a team leader. Good people management, project management, problem-solving, and decision-making skills
  • Excellent written and verbal communication skills. Demonstrated experience authoring CMC dossiers required
  • Ability to interact with staff from multiple departments and offices to establish project standards.
  • Good attention to detail, flexibility, and open to suggestions. Good initiative, adaptability, and pro-activity
  • Computer literacy in MS Word, Excel, Adobe, and PowerPoint.
  • Additional Information :
  • Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

    Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

    The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

    Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.

    Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

    The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

    Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

    All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.

    Primary Location

    Europe - AUT-Home-Based

    Other Locations

    Europe - POL-Home-Based, Europe - PRT-Home-Based, Europe - ITA-Home-Based, Europe - SVK-Home-Based, Europe - ROU-Home-Based, Europe - DEU-Home-Based, Europe - HUN-Home-Based, Europe - BGR-Home-Based, Europe - IRL-Home-Based, Europe - FRA-Home-Based, Europe - SRB-Home-Based, Europe - NLD-Home-Based, Europe - GBR-Home-Based, Europe - ESP-Home-Based (Madrid), Europe - BEL-Home-Based, Europe - GRC-Home-Based, Europe - CZE-Home-Based, Europe - ESP-Home-Based (Barcelona)

    Employee Status

    RegularExpected Salary Range : 1

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