Responsible for directing innovative global CMC regulatory strategies for product development and approval.
Responsible for defining strategies for meeting and keeping 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 support for various departments, projects, and teams/committees.
Manage direct reports.
- Responsible for directing global regulatory CMC strategies for assigned projects and programs.
- Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
- Provide regulatory guidance to company personnel throughout the research and development process.
- Direct the organization and preparation of clear and effective submissions.
- Prepare and deliver effective presentations for external and internal audiences.
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
- Develop and maintain highly capable and dedicated regulatory staff. Guide subordinates in carrying out responsibilities. Responsible for coordinating subordinate activities and career development.
- Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
- Provide leadership on project teams and subcommittees.
- Allocate representation on relevant project teams.
- Provide input to Regulatory Senior Management teams.
- Foster a global view as part of the whole regulatory team.
- 8 years pharmaceutical/biotechnology industry experience with technical management experience.
- Minimum of 6 years in RA.
- Good 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.
- Experience in interfacing with relevant regulatory authorities.
- Foster effective, positive interactions with regulatory agencies, and corporate partners.
- Ability to lead and influence project teams, committees, etc. to attain group goals.
- Demonstrate excellent 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.
- Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.
- Well organized, detail oriented, effective written and oral communication skills.
- Supervisory experience.
- Ability to guide, train, supervise and prioritize workload of direct reports.
- Computer literate.
- Knowledge of local and international GMP requirements.
- Experience in assessing compliance of CMC documents with current Guidelines and Regulations. Capable of recommending strategies to achieve such compliance.
- Experience in assessing impact of proposed CMC changes to licenses or clinical trial applications.
BS degree in sciences, preferably life science