Title: Executive Director, Regulatory Affairs
Location: Waltham, MA (can work 2-3 days remote OR one week remote and the following onsite)
Contract Duration: 12 Months
Rate: To be discussed
Working closely with the community, my client intends to further accelerate innovation for people with rare blood disorders. The company will focus on advancing pipeline programs to address areas of unmet medical need in hemophilia and other blood disorders, including sickle cell disease, where the client plans to bring an enhanced focus on developing treatments for this underserved patient population. This position is responsible for directing multiple innovative global 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 guidance for various corporate wide teams/committees. Manage direct reports. May have budget responsibility for a Functional Area.
- 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 and advises team on changes that could impact future development.
- 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 trials and 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.
- May be responsible for line management and development of direct reports.
- 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.
Key Contacts and Interactions:
- Interacts with multiple departments at all levels.
- Interact with a wide variety of outside contacts, including contractors, corporate partners and regulatory agency personnel.
- May have direct reports.
- 10 years pharmaceutical/biotechnology industry experience with technical management experience.
- Minimum of 7 years in RA.
- 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.
- Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
- Comprehensive knowledge of GCPs and GLPs.
- 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.
- Ability to guide, train, supervise and prioritize workload of direct reports, as required.
- International regulatory experience preferred.
- Experience in the development of therapies for rare (orphan) and/or extremely rare (ultra-orphan) diseases desirable.
- BA/BS/University degree required, Life/Health Sciences preferred
- Graduate degree preferred
Sthree US is acting as an Employment Business in relation to this vacancy.