Description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Own and manage regulatory projects accounts and work towards achieving excellence in service delivery and exceeding Service Level Agreements through team of delivery manager and project managers.
- Lead the team of cross functional regulatory affairs specialist to support global specification management, raw material qualifications, change control, toxicology, analytical methods and stability reports, packaging material, labelling etc. for global product portfolio including cosmetics/consumers, pharmaceutical, medical devices and biologics.
- Set up matrix team of regulatory affairs professionals to manage the post approval life cycle maintenance. Lead and manage the regulatory affairs functions; manage delivery of regulatory affairs projects for global customers across all geographies including US, EU, APAC, MENA, LATAM, CIS etc.
- Participate in and/or lead business development activities e.g., RFI and RFP responses, lead bid defense efforts for potential new regulatory affairs project opportunities.
- Provide guidance/direction for regulatory affairs staff on development and training needs. Responsible for ensuring that staff are available for projects requiring regulatory submissions services.
- Responsible for defining RA strategies to meet submission timelines for post approval life cycle maintenance, for implementing these strategies and for the ongoing assessment of the appropriateness for continuing established regulatory strategies and for adjusting the strategies as appropriate.
- Interface with project management office to generate process productivity metrics and communicate them at appropriate forums.
- Interface with audit and compliance team to manage QA related issues/escalations within the account
- Ensure customer satisfaction targets are met and exceeded.
Experience (Minimum Required):
- Minimum of 15 years experience in the pharmaceutical industry in Regulatory Affairs or Regulatory Operations, ideally at least 10 years international regulatory affairs/operations experience in approvals and post approval product life cycle maintenance.
- Expertise in project governance, escalation, issue resolution and other project management skills
- Experience of PL management
- Experience in transition of business processes to an offshore location
- Experience in budgeting, forecasting and pricing
- Excellent written and verbal communication and interpersonal skills
- Ability to manage relationships across diverse set of stakeholders
- Ability to produce quality materials within tight timeframes
- Good Negotiation skills
- Willingness to work in a flexible schedule.
