Regulatory Program Director

- Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment. Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, and regulators
- Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
- Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
- Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
- Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary
- Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
- Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines
- Develops regulatory risk management and contingency plans. Communicates plans to management, as appropriate

* Average of 7 or more years' relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
* Broad understanding of international regulations, processes and issues in drug/biologics development. Includes in-depth knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
* In-depth experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
* Bachelors Degree required (life sciences disciplines strongly preferred); Advanced Degree in related field is preferred

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