BioMarin Regulatory Affairs
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin's Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients' lives.
This role is Global Regulatory Lead responsible for the management of product in late-stage development and life cycle management, including development of new indications.
The Global Regulatory Lead will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading the Global Regulatory Team (GRT) and developing and executing comprehensive, integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and rest of world).
The GRL role is a critical matrixed team leadership role and is Regulatory voice at the Core team and Corporate Governance forums representing and accountable for the global regulatory strategy. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.
- Duties Responsible for leading GRT and directing global regulatory strategies for assigned program and ensuring execution of these strategies.
- Direct global clinical and pre-clinical regulatory strategies for development and global life cycle management of products.
- Support development of the late-stage clinical development plan.
- Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
- Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages. Guide the team by creating a shared understanding of global submission priorities and requirements understanding any impact on individual and collective regulatory resources and/or translate into resource needs so that priorities can be met.
- Oversee and ensure timely execution of HA meetings in line with the GRP and available guidance's, ensuring reviews of planned Health Authority interactions, risks, and mitigations ensuring they are incorporated into the GRP and aligned with core team and corporate goals.
Work with the regional/functional lead for the creation of global regulatory submissions and plans for heath authority interactions as defined in the GRP (e.g., CTAs, MAs, variations/supplements, annual reports, ODD, response to questions, expedited review requests, etc.) to ensure there is clarity of roles/responsibilities required to obtain timely deliverables.
- Serve as an advisor/reviewer of content for INTL agency meetings and submissions (i.e., ODDs, MAs, RTQs), and MA maintenance (i.e. amendments, renewals, PMCs, safety reporting etc.)
- Ensure fulfillment of global clinical and nonclinical PMRs/PMCs, including timely and effective communication of HA feedback (post-marketing study expectations and commitments/milestones) to relevant partner teams and the GRT; liaise with regional stakeholders on the global PMR fulfillment status and any relevant HA feedback, as appropriate
- Develop and maintain the Core Global Dossier and collaborate with lead global labeling team on the company Core Data Sheet.
- Collaborate with project managements to direct the organization and preparation of clear and effective submissions and timings.
- Prepare and deliver effective presentations for external and internal audience.
- Provide input to regulatory strategy forums with Regulatory Senior Management teams and represent Regulatory at governance forums.
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
- Mentor Regulatory Managers and guide direct reports in carrying out responsibilities.
- Responsible for coordinating activities and career development of direct reports.
- Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
- Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
- Maintain a global view as part of the whole regulatory team.
- Advocate for BioMarin by building strong relationships with Health Authorities and other external stakeholders as required to facilitate sound decision-making.
- Take steps to actively improve interdepartmental communications.
- Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
- May have presence on external regulatory committees/trade associations
Decision Making and Problem Solving, including an ability to coach and mentor teams to develop creative and novel solutions.
Influence, Cross-Functional Collaboration and Organizational Awareness, including an ability to leverage organizational knowledge, tact, and connections to stakeholders across the organization to extract necessary information quickly and effectively while strengthening inter-departmental relationships.
Agility and Proactivity, such as consistently expecting, driving for and delivering excellence and optimal outcomes.
Leadership, such as skill in building high functioning, effective teams that receive positive feedback from stakeholders.
Communication, including an ability to ensure that employees, at all levels, fully understand their roles in achieving success.
Strategic Thinking and Planning, such as an ability to hold in mind the vision and purpose of the function, along with broader company objectives, when making decisions.
Regulatory Strategy and Frameworks: such as an ability to effectively develop and represent the regulatory position/solution in challenges associated with lifecycle/commercialization.
Scientific Writing for Regulatory Submissions: Able to conduct comprehensive regulatory submission document evaluations including evaluation of the quality and completeness of content.
EDUCATION AND EXPERIENCE
- Degree in health or life sciences, significant experience in Global regulatory affairs including the post-approval management of product licenses, expanding indications, and of the regulatory aspects associated submitting and maintaining licenses at a country level. Knowledge of regulatory frameworks at Global level, and the ability to apply these to regulatory solutions. Experience in management/leadership, development and retention of high-quality regulatory affairs professionals.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.