VP, Regulatory Strategy – Woburn, MA
Summary of job description:
The VP, Regulatory Strategy reports to the SVP, Regulatory, Quality Assurance and Safety and develops and executes clinical regulatory strategies and activities. This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of clinical documents to regulatory authorities, oversight of the preparation of meeting requests and briefing documents to obtain regulatory advice collaborating with development partners, and maintaining compliance with applicable regulatory requirements. This position will work in partnership with CMC Regulatory Affairs to co-develop a fully integrated regulatory strategy.
- As a member of the development leadership team, help build, develop, lead and drive the overall clinical regulatory strategy for the company’s clinical pipeline that ensures scientific value creation across lifecycle towards initial approval, launch, and label expansions.
- Provide leadership and guide the overall clinical regulatory strategy for all programs from early development through regulatory submissions and post-commercialization, with an emphasis from mid to late stages of development.
- Influence strategy to address internal or external business and regulatory issues and proactively identify potential strategic issues and opportunities.
- Drive and execute the clinical regulatory activities that lead to successful IND/CTA and global MAA filings for new cancer therapies.
- Identify, assess and communicate potential risks associated with development and regulatory strategy scenarios and plan risk mitigation strategies.
- Interact directly with global regulatory agencies and ensure that interactions are properly communicated to the clinical team and/or business partners. Triage, coordinate and manage responses to questions from regulatory authorities by collaborating with the clinical teams to address regulatory agency feedback and define long and short ranged actions.
- Responsible for the coordination, timely preparation, review and submission of clinical documentation packages for regulatory agency interactions (e.g. FDA pre-/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
- Develop submission plans and timelines for clinical sections and in partnership with CMC Regulatory for coordination with CMC and nonclinical sections.
- Direct or manage resources of the authoring and preparation of clinical sections as applicable.
- Reviews clinical and technical documentation for regulatory compliance and inclusion in submissions to global regulatory agencies.
- Work collaboratively with cross functional teams, including clinical development, clinical operations, translational research, safety and medical affairs to manage activities and/or development and changes related to clinical protocols, investigator brochures and commercialization.
- Provides regulatory input and guidance for the clinical development
- Evaluate clinical protocols, protocol deviations, and clinical trial documentation for impact on submissions and filing requirements.
- Develop and maintain the company core data sheet and leads cross functional labeling meetings
- Review all promotional labeling and advertising for clinical trial and commercial labeling.
- Work to further develop infrastructure for Regulatory Affairs regarding documentation preparation and submissions.
- Contribute to initiatives to improve processes within the Regulatory department.
- Develops and maintains current regulatory knowledge and keeps up with/implements the changes required for regulatory compliance. Knowledge of EU and rest of world (ROW) clinical trial application requirements.
- Review SOPs and protocols with regard to regulatory matters.
- Performs other appropriate administrative duties, such as preparing correspondence and filing, where necessary
- Maintains regulatory documentation including submissions to and correspondence with each governing authority
- Provide mentoring to staff and have skill sets for directly managing staff.
- Manage external regulatory consultants and project deadlines, as needed.
B.A or B.S. degree, MS or PhD preferred, in an appropriate scientific field with 20+ years’ experience in Pharmaceutical/Biotech Industry with 10+ years in a Clinical Regulatory Affairs, capacity.
Experience and skill requirements:
- Strategic leader with demonstrated success building, managing and developing teams is required.
- Professional knowledge and skills working with solid tumor oncology therapeutics is required with biologic, gene therapy or vaccine experience preferred.
- Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities but with a willingness to be hands on and does not delegate responsibilities.
- Previous experience in representing the sponsor in front of regulatory agencies and as primary regulatory author for regulatory submission documents in preparing successful regulatory submissions (BLA, MAA, IND, CTA, etc.) to the global regulatory authorities
- Expedited approval pathway, rare disease, and commercial experience preferred
- Highly knowledgeable in ICH, FDA and EMA regulations and guidelines and experience working in a global environment
- Skilled in multiple computer-based tools, in addition to software programs such as MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio
- Strong interpersonal, organizational, and time management skills with attention to detail
- Ability to work independently and manage multiple projects in a fast-paced environment
- Capable of handling matters of strict confidentiality and sensitivity
- Appropriate GCP or GXP training
- Prior management of budgets is expected.
- Prior experience with vendor selection and management is expected.
- Experience with the development and support of related SOPs and policies is expected.
- Experience with partnerships and strategic alliances is expected.
- Ability to relate and work with a wide range of people to achieve results.
- Impactful written and verbal scientific communication skills.
- Successful and superior influencing skills across all levels of the organization and with external collaborators.
- Problem solving and risk-mitigation skills.
- Ability to build working relations throughout the organization and with business partners to achieve business goals.
- Ability to travel approximately 15% of time
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.