Director, Global Site Activation & Regulatory Affairs Strategy
SUMMARY: Responsible for developing a robust global site activation and regulatory strategy for assigned projects including identification of regulatory risks and potential mitigations. Supports the sales process by translating the regulatory strategy into compelling proposal text and representing the Site Activation team at Bid Defense Meetings. Serves as an expert resource for other members of the Site Activation department to ensure appropriate execution of the developed global regulatory strategy.
Tasks may include but are not limited to:
- Responsible for developing together with the assigned Regulatory Affairs Lead (RAL) the regulatory strategy for assigned projects. Designing and assessing regulatory strategy options on a regional and global basis.
- When required, ensuring active feed-back from and agreements with Medical Writing, Medical and Scientific Affairs team members as appropriate.
- Provides input to the Medical & Scientific Affairs team with regards to Clinical Development programs.
- Review of technical documentation (i.e.: protocol, IB, master SIS/ ICF) as contracted.
- Create and/or review IMPDs, summary of IMPDs (as contracted)
- Responsible for the development of regulatory risk assessments for assigned projects and supports the development of strategies to mitigate identified risks. Keeps abreast of changes in the regulatory environment to anticipate necessary strategy adaptations including key areas of focus for Worldwide’s customers (ex. rare/orphan diseases, biosimilars, gene therapy, etc).
- Ensures early identification of major regulatory issues relating to clinical, technical, strategic or operational information impacting successful Clinical Trial Authorizations approvals for assigned projects. Identifies corrective regulatory measures and immediate actions required in case of deviations jeopardizing project delivery.
- Provides input into which Patient facing materials and Patient Recruitment strategies would be acceptable and preferable from a regulatory perspective at a regional and country level.
- Implement short-term and long-term objectives, major plans and programs of the Site Activation division to ensure they align with and enhance the achievement of corporate strategy and objectives.
- Mentor Regulatory Affairs team and guide mentees in developing advanced skills in strategic Regulatory planning, risk identification and mitigation and sponsor engagement.
- Responsible for developing compelling proposals and to provide department representation at business development meetings.
The responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Comprehensive knowledge of applicable regulations.
- Extensive experience in interpretation regulations, guideline, policy statement, etc…
- Extensive experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Excellent planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Superior written and verbal communication skills to clearly and concisely present information
- Experienced problem solving/decision making skills.
- Excellent attention to detail.
- Strong knowledge of ICH-GCP Guidelines as well as relevant federal and regulations, law, decree and guidelines. Understanding of standard operating procedures.
- Knowledge of Word, Excel, Powerpoint and Outlook
- Subject Matter Expert in one or more regulatory speciality (Biosimilars, Gene Therapy, Rare Diseases, Clinical Development, etc)
- Advanced degree (M.D., Ph.d., D.V.M. or Pharm.D. in life sciences) with three to five years’ experience in regulatory affairs activities OR M.S. degree (in life sciences) with ten years’ in regulatory affairs activities OR B.S. degree with ten plus years of experience in regulatory affairs activity.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently