Job Title: Head/VP, Regulatory Affairs
Job Number: 22302
Location: Boston, MA
The US Head of Regulatory Affairs will lead and oversee all aspects of Regulatory Affairs supporting the US subsidiary. The primary scope of the US Head of Regulatory Affairs role is to provide leadership in US for pre-approval and marketed products. S/he will contribute to the development and execution of a harmonized global regulatory strategy, and effectively represent the US market needs.
S/he will be a strategic, highly collaborative executive who brings significant regulatory experience for early and late-stage clinical development programs and marketed products. S/he will provide strong management of regulatory processes to assure optimal product approval and commercial success. S/he will be responsible for negotiating with the FDA and will be equipped to handle challenges and to apply regulatory principles to achieve preferable business objectives and regulatory results. Preferably, this leader will have experience preparing and executing an FDA Advisory Committee meeting, and ideally an Oncology Drug Advisory Committee meeting. Leadership experience in the development and submission of regulatory dossiers to the FDA is within scope.
The successful candidate will likely have a mix of regulatory knowledge of drug development, including clinical trial requirements, trial design and data analysis, post-marketing surveillance, manufacturing, quality, marketing and sales. The candidate will be expected to interface with senior management, potential alliance partners, and external contracted operational sites in achieving the highest standards in regulatory and quality compliance.
Key responsibilities include:
- Build regulatory policies and procedures for the US subsidiary, including for commercial products.
- Provide strategic input and leadership to the Company investigational programs (as applicable) and the business team, with respect to developing and executing a regulatory strategy, including submission and filing strategy of the breakthrough therapy designated (BTD) lead compound, .
- Create and maintain all US regulatory submission plans and lead regulatory submission process in the US.
- Serve as primary liaison with regulatory authorities at the FDA.
- Develop strategy for pre-meeting briefing materials, lead the preparation for and facilitate sponsor interactions at regulatory meetings, and ensure appropriate follow-up.
- Partner with Research and Development, Medical affairs and commercial colleagues to define and execute regulatory review process.
- Ensure appropriate regulatory compliance in the conduct of external communications, development programs, Quality programs and reporting to the FDA.
- Manage US regulatory budget and resources.
- M.D. or Ph.D. preferred, but not required. Relevant degree, preferably advanced degree, in life science, pharmacy, chemistry or equivalent studies required.
- Experience in regulatory affairs, with minimum of 12 years’ experience in pharmaceutical industry is required.
- Oncology experience strongly preferred
- Track record of hands on experience of regulatory submissions and approvals in US
- Advanced understanding of the drug development and approval process
- Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective global collaboration
- Outstanding verbal and written communications
Strong Business Acumen:
- Strong judgment, prioritization and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies.
- Anticipates future consequences and trends; has broad knowledge and perspective; future oriented; can articulate risk vs. benefit and create competitive strategies.
- Understands key profitability drivers and market opportunities to optimize business return on investment, while also focusing on science and innovation.
- Makes sound business decisions that reflect knowledge of cross-functional interdependencies; seeks and analyses data from a variety of sources to support decisions and to align others.
Executes for results:
- Focuses on external trends and uses knowledge of industry, competitors, political and regulatory landscape, geography and culture to inform decisions.
- Sets clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results.
- Comfortable with ambiguity; adapts nimbly and leads others through complexity.
- Has a high degree of integrity in his/her approach to making decisions; acts in a transparent and consistent manner while always taking into account what is best for Company.
- Possesses personal leadership qualities that inspire trust, respect, credibility and confidence of peers and colleagues and takes the organization to a higher level.
- Effective, inspirational leadership abilities working within a highly collaborative environment.
- Drives, leads, and manages through organizational change and times of ambiguity. Challenges the status quo; focuses on continuous improvement to yield greater productivity.
- Demonstrated ability to motivate, mentor, manage and provide clear, unambiguous expectations and priorities for the team (own staff or through networks).
- Comfort and confidence in working with diverse teams and backgrounds.
Relationships and Influence:
- Works effectively and transparently, collaborates cross-functionally, exercises influence at senior levels, and builds alignment around goals and objectives.
- Articulates vision and direction clearly and concisely in a variety of scientific and business forums, and communicates and effectively influences across functional, hierarchical, cultural, and geographic boundaries.
- Possesses unquestioned integrity and strong ethics. Demonstrates commitment to the company’s beliefs, values and organizational goals.
- Ability to influence key external organizations globally and be an external advocate for Company.
- Effectively collaborates with and influences partners to achieve goals and resolve conflicts across organizations.
- Possesses excellent interpersonal, analytical, communication (written and oral), in addition to results oriented project management skills.