This position is responsible for directing multiple innovative global regulatory strategies for commercial support, geographic expansion and LCM. Responsible for defining strategies for meeting and while post approval compliance. Responsible for regulatory documents, submissions, and compliance issues. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory guidance for various corporate wide teams/committees.
- Develops the global regulatory strategy for assigned programs through collaboration with a cross functional team.
- Advises project teams regarding the development and implementation of regulatory strategy. Maintains awareness of the changing regulatory landscape.
- Develops innovative life cycle management plans to achieve business objectives.
- Direct the organization and preparation of clear and effective submissions.
- Establishes and maintains relationships with regulatory agency personnel. Negotiates directly with regulatory authorities regarding company's filings.
- Serves as regulatory affairs executive to provide input on filing activities and to ensure that report systems are maintained and compliant.
- Collaborates with other departments as well as corporate or marketing partners and outsourcing partners to achieve project goals.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Reviews all external materials for regulatory compliance.
- Represent Regulatory Affairs on cross-functional project teams
- Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the internal management teams as well as the executive management team.
- Prepare and deliver effective presentations for external and internal audiences.
- Identify areas in need of improvement and lead the development and implementation of process improvements.
- Create an environment conducive to a global view as part of the whole regulatory team.
- Take steps to actively improve interdepartmental communications and efficiency.
- Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
- May have presence on external regulatory committees/trade associations.
- Interacts with multiple departments at all levels.
- Interact with a wide variety of outside contacts, including contractors, corporate partners and regulatory agency personnel.
Minimum of 10 - 15 years of experience.
- BA/BS/University degree required, Life/Health Sciences preferred. Doctoral degree in the sciences, Pharmacy or Regulatory Science preferred.
- Comprehensive knowledge of applicable regulations.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Comprehensive knowledge of cGMP’s.
- Extensive experience in interfacing with regulatory authorities.
- Ability to lead and influence project teams, committees, etc. to attain group goals.
- Demonstrated leadership and communication skills.
- Ability to represent the department in project teams, committees and external meetings.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
- Well organized, detail oriented, effective written and oral communication skills.
- International regulatory experience preferred.