The Executive Director, Regulatory Affairs will report to the
SVP & Head, Translational Medicine, Clin. Pharm. & Reg.
The Executive Director, Regulatory Affairs will be responsible
for developing and executing the global regulatory strategy for one
or more projects. This individual will, with a high sense of
urgency, provide strategic and operational regulatory input to
cross-functional teams responsible for global development programs.
The individual will also ensure effective communication and
constructive working relationships with business partners and
representatives of regulatory authorities.
Responsibilities and Duties
Provide a bullet point list of the responsibilities and duties
of this job.
Using experience in regulatory affairs and drug development,
prepares global regulatory strategy for compounds in development
starting from IND/IMPD to NDA/MAA submissions. Leads the
development and preparation of regulatory documents, with input
from global product team members. Documents must meet current
regulatory standards (for e.g. FDA, EMA, MHRA, etc) and must be of
high quality, consistent, and approvable by regulatory authorities.
This includes, but may not be limited to, IND, Type B or C meeting
documents, EOP2, NDA/MAA documents prepared in the electronic
Common Technical Document (eCTD) format,
Responsible for the preparation of regulatory documents such as
Orphan Drug Applications, Pediatric Study Plans, Pediatric
Investigational Plans, EMA Scientific Advice documents, etc
Prepared DSUR and/other documents to meet annual reporting
Leads IND maintenance to support all clinical development
Manages and participates in post-approval, global product
activities. This includes, but may not be limited to, change
control, product complaints, supplements and variations leading to
Works with the team to develop a timeline for responding to
regulatory inquiries from global regulatory agencies to ensure
issues are addressed in a timely manner. Assists in the preparation
and review of responses to global health authorities.
Participates in regulatory health authority meetings and assists
with the preparation of meeting request, meeting packages and
Reviews and edits technical documents provided by the clinical,
clinical pharmacology and nonclinical functions and extracts
information necessary for regulatory submissions. This may also
involve recommending changes to technical documents to ensure
conformance with existing regulatory approvals.
Remains current on regulatory guidance documents from the FDA,
EMA, ICH, etc.
Directs regulatory strategy development and implementation for
allocated products. Effectively interprets regulatory guidance and
provides recommendations to key stakeholders.
Actively collaborates with development teams to execute US
regulatory strategies and contingencies for assigned projects from
IND, to NDA to post-marketing activities. Plans and manages
regulatory activities, including the development and maintenance of
regulatory budgets and timelines. Ensures adherence to relevant
regulatory guidance and regulations, as well as company Standard
Operating Procedures (SOPs). Participates in decision-making and
Creates, maintains, and executes regulatory project plans,
timelines, and other tools required to facilitate planning and
coordination of deliverables for each assigned Project. Facilitates
the development of the integrated project plans relevant to the
regulatory deliverables and ensures alignment across relevant
functions and smooth transitions among pipeline stages. Facilitates
contingency and risk mitigation planning.
Interacts with head of regulatory and other Sr. Management /
executive levels. Exercises judgment and exerts influence on the
overall objectives and long-range goals of assigned projects. May
represent the department in relevant internal/external
Responsible for development and implementation of regulatory
strategies for BXCL501 dementia, opioid withdrawal and follow up
Responsible for the development an implementation of regulatory
strategies for BXCL701 including strategies for neuroendocrine
prostate cancer and pancreatic cancer
Manages regulatory operations for programs under management
At least 15 years in pharmaceutical industry regulatory affairs,
including experience in leading regulatory teams and participating
in cross-functional development teams.
Strong knowledge of drug development and regulatory policy;
excellent scientific and business judgment.
Experience in all phases of development across multiple
therapeutic areas including IND, NDA, and CTA experience.
Master’s, Pharm D, or PhD Degree in a related discipline
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