Manager Regulatory Affairs

Manager Regulatory Affairs

PPD - Pharmaceutical Product Development

Sofia, Bulgaria

We have a position open for a Manager Regulatory Affairs in our Regulatory Intelligence, Policy & Advocacy (RIPA) Team. This role holds people management responsibilities, provides technical/project leadership across regions, proposes innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. The role also provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, and acts as liaison with internal and external clients in the provision and marketing of these services.

Responsibilities

  • Manage a team of Regulatory Intelligence professionals based across time-zones, including regular 1:1 meetings, goal setting and year-end assessments; career development discussions and support, motivation and issue resolution, task assignment and prioritization;
  • Act as an administrator for our in-house Regulatory Intelligence database, taking a lead role in directing team members, RI collaborators and support groups (e.g., Process & Systems Optimization) to ensure intel is accurate, maintained and easily accessible by cross-functional audience;
  • Supports generation and review of Regulatory Intelligence metrics on a quarterly basis, and takes necessary actions to ensure metrics targets are met and PPD Regulatory Intelligence function acts in a lean capacity;
  • Directs team members in the handling of business-critical regulatory intelligence to support changing business needs;
  • Provide senior review and advice to prepare Regulatory Intelligence briefings and client deliverables and ensure high quality standards that meet or exceed client expectations, local and regional requirements;
  • Effectively manage a small network of external vendors including obtaining of Quotes, purchase orders activation in the system as well as verification and approval of invoices, effective communication with vendors and timely resolution of issues;
  • Lead and/or participate in various Regulatory Intelligence Forums and management meetings. Proactively propose suggestions to contribute to the efficient management of the RIPA Team;
  • Ensure quality performance for key/managed projects;
  • Manage project budgeting/forecasting functions. Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications;
  • Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments;
  • Provides matrix/project leadership, training and guidance to junior team members;
  • Ensure compliance with relevant organizational and regulatory SOPs and WPD/GDs;
  • Participate in launch meetings, review meetings and project team meetings.

Job Qualification

What the role requires you to have:

  • Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification;
  • Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years;
  • Proven project management experience, and experience performing effectively in a client facing role.

Knowledge, Skills and Abilities:

  • Excellent English language (written and oral) communication skills as well as local language where applicable;
  • Excellent attention to detail and quality as well as excellent editorial/proofreading skills;
  • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments;
  • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies;
  • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects;
  • Excellent negotiation skills;
  • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables;
  • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.;
  • Superb understanding of medical terminology, statistical concepts, and guidelines;
  • Excellent analytical, investigative and problem-solving skills;
  • Excellent understanding of budgeting and forecasting.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies