Job title: Global Regulatory Lead
Location: Morristown, NJ / Cambridge, MA
Main Responsibilities:- Accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well as for life cycle management of products. Responsible for proactively contributing to the Target Product Profile (TPP), ensuring competitive profiles in alignment with the business objectives
- Accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives and setting clear expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects. The role will supervise, coach, and facilitate a feedback culture within the GRT to develop team performance. The GRL is expected to develop a team of Regulatory Strategists (RS) as appropriate.
- The GRL is accountable for ensuring alignment and communication internally and externally as "one GRA voice" with TA, GBU Head and up to the GRA LT when needed to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate
- Identify opportunities to support the team to identify regulatory acceleration opportunities, take thoughtful risks, accept challenges, and making final decisions on the regulatory success rates and mitigations on behalf of the GRT
- The role is accountable for monitoring and interpreting the global regulatory environments and accountable to ensure that it leverages expertise in other parts of GRA (e.g. Regional experts) in order to ensure that most robust strategy possible and is accountable for determining any updates to the regulatory strategy accordingly
- Leads development of global HA interaction plan and strategy in collaboration with GRT. Is accountable for the communication of the key outcomes to senior management
- Advances the organization's goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned therapeutic area and projects in collaboration with the Regions.
About YouRequirements:- BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred
- At least 8-10 years of relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global), especially in the development phase, with oncology experience
- Demonstrated expert regulatory strategic experience and understanding of the regulatory environment to develop regulatory strategies
- Ability to work strategically within a sophisticated, business critical and high-profile development program
- Experience being accountable for developing and defending innovative regulatory strategies at Global Project Teams or equivalent forum
- Previous experience in leading Health Authority interactions in major markets
- Strategic regulatory leadership expertise with experience in developing and implementing successful regulatory strategy and with preparation of (s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority within a major market (e.g. US, EU)
- Experience leading filings/registrations and obtaining a regulatory action in a major market(s)
- Project leadership experience
- Experience leading a team and/or developing internal talent
Why Choose Us? - Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
The salary range for this position is:
$178,500.00 - $257,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
