Sr. Manager, Regulatory Affairs International
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.
Manage a US-based team that supports regulatory activities for the Canada, LATAM, MEA CIS and APAC regions, ensuring strategic alignment with commercialization efforts, and support other product activity as needed.
Leads and participates on interdisciplinary regulatory teams responsible for defining and implementing regulatory strategy, including plans to submit Marketing Applications globally.
Provides regulatory leadership on cross-functional development teams. Manages and mentors regulatory professionals to achieve regulatory objectives in line with individual development and corporate goals.
- Understand regional laws, regulations, guidance, and global regulatory and political developments while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.
- Lead/participate on interdisciplinary regulatory teams in establishing global regulatory strategy
- In conjunction with regional leads and experts, oversee planning, preparation, and submission of marketing applications, orphan drug applications and variations to support LATAM, MEA CIS and APAC regions.
- Manage and mentor associate/senior associate/manager-level direct reports.
- Provide regulatory support to team members located in global offices.
- Manage the writing or updating of various sections of the MAs including the administrative, labeling, nonclinical, and clinical portions of MAs.
- Act as a main point of contact for specific projects and serve as an international regulatory representative on project subteams. The candidate will need a thorough understanding of commercial plans in order to provide insights on the feasibility for market entry.
- Provide strategic regulatory insight to the project team.
- Communicate with regulatory consultants regarding product development plans.
- Interact with executive leadership team to discuss global regulatory plans.
- Perform regulatory intelligence searches for registration and other regulatory requirements in applicable global regions.
- Minimum of 12years of related experience with at least 5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the Regulatory environment. International regulatory experiencepreferred. Clinical development a plus.
- Experience with managing and mentoring junior staff.
- Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions
- Ability to successfully manage multiple projects to deadlines.
- Thorough understanding of relevant drug development and post-marketing regulations and guidelines and have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
- Skilled at gathering supportive information and developing product approval strategies
- Proven track record of achieving regulatory goals in ambiguous and sometimes challenging situations
- Proficiency with computer and standard software programs is required. Candidate must be fluent in English, both verbal and written (technical).
- Rare disease experience is preferred
- International experience is preferred
- Biologics experience is preferred
- Bachelor's degree preferably in a science/life sciences.