Vivid Resourcing
Director/Senior Director, CMC Regulatory Affairs
Vivid Resourcing, Boston, Massachusetts, us, 02298
Director / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality)
Boston area (hybrid, flexible travel)
A clinical-stage biotech developing an
advanced biologic therapy in Phase 3
is seeking a
Director/Senior Director of Regulatory Affairs, CMC
to lead regulatory strategy and execution for a pivotal autoimmune program approaching
BLA submission .
This is a
high-impact leadership role
suited to someone who combines deep regulatory CMC expertise with the agility to work cross-functionally in a lean biotech setting.
The Opportunity: You’ll be the
CMC regulatory lead
driving global submission strategy, from IND maintenance through BLA authoring and post-approval planning. You’ll partner closely with Manufacturing, Quality, and Supply Chain teams, shaping how the company engages with regulators across major markets.
Key Responsibilities:
Define and implement
global CMC regulatory strategy
for a late-stage biologic asset (Phase 3 → BLA).
Lead preparation, authoring, and review of
CMC sections
for IND, BLA, and global submissions.
Develop and execute the
BLA roadmap , determining content strategy, data presentation, and agency engagement plans.
Serve as the
primary CMC regulatory point of contact
with the FDA and other global agencies.
Partner cross-functionally with Manufacturing, Quality, and Technical Operations to ensure regulatory alignment throughout process development, validation, and lifecycle management.
Guide the organization on
advanced modality
expectations and best practices in biologics manufacturing.
Contribute to future
device strategy
(auto-injectors, prefilled syringes, infusion/IV delivery systems), helping define regulatory pathways for combination products.
Mentor and support junior regulatory professionals or cross-functional contributors, though this role is
not directly managerial
at present.
What We’re Looking For:
10+ years of
Regulatory Affairs experience , including direct
CMC responsibility
within biologics.
Proven track record supporting
late-stage submissions
(Phase 3 → BLA) and global regulatory filings.
Strong understanding of
manufacturing and analytical
CMC considerations for biologics.
Ability to build and execute
global regulatory strategies
across the U.S., EU, and other key regions.
Experience in
advanced modalities
or
drug–device combinations
highly preferred.
Collaborative communicator who can influence senior stakeholders while remaining detail-focused.
U.S.-based, with ability to travel to the Boston area a few times per quarter.
Why Join:
Opportunity to
own regulatory strategy
for a pivotal Phase 3 biologic asset.
Work within a
nimble, science-driven biotech
backed by strong scientific and operational teams.
Operate with
autonomy and visibility
across the full product lifecycle, from late clinical stage through potential licensure.
Reach out directly for a confidential discussion:
#J-18808-Ljbffr
A clinical-stage biotech developing an
advanced biologic therapy in Phase 3
is seeking a
Director/Senior Director of Regulatory Affairs, CMC
to lead regulatory strategy and execution for a pivotal autoimmune program approaching
BLA submission .
This is a
high-impact leadership role
suited to someone who combines deep regulatory CMC expertise with the agility to work cross-functionally in a lean biotech setting.
The Opportunity: You’ll be the
CMC regulatory lead
driving global submission strategy, from IND maintenance through BLA authoring and post-approval planning. You’ll partner closely with Manufacturing, Quality, and Supply Chain teams, shaping how the company engages with regulators across major markets.
Key Responsibilities:
Define and implement
global CMC regulatory strategy
for a late-stage biologic asset (Phase 3 → BLA).
Lead preparation, authoring, and review of
CMC sections
for IND, BLA, and global submissions.
Develop and execute the
BLA roadmap , determining content strategy, data presentation, and agency engagement plans.
Serve as the
primary CMC regulatory point of contact
with the FDA and other global agencies.
Partner cross-functionally with Manufacturing, Quality, and Technical Operations to ensure regulatory alignment throughout process development, validation, and lifecycle management.
Guide the organization on
advanced modality
expectations and best practices in biologics manufacturing.
Contribute to future
device strategy
(auto-injectors, prefilled syringes, infusion/IV delivery systems), helping define regulatory pathways for combination products.
Mentor and support junior regulatory professionals or cross-functional contributors, though this role is
not directly managerial
at present.
What We’re Looking For:
10+ years of
Regulatory Affairs experience , including direct
CMC responsibility
within biologics.
Proven track record supporting
late-stage submissions
(Phase 3 → BLA) and global regulatory filings.
Strong understanding of
manufacturing and analytical
CMC considerations for biologics.
Ability to build and execute
global regulatory strategies
across the U.S., EU, and other key regions.
Experience in
advanced modalities
or
drug–device combinations
highly preferred.
Collaborative communicator who can influence senior stakeholders while remaining detail-focused.
U.S.-based, with ability to travel to the Boston area a few times per quarter.
Why Join:
Opportunity to
own regulatory strategy
for a pivotal Phase 3 biologic asset.
Work within a
nimble, science-driven biotech
backed by strong scientific and operational teams.
Operate with
autonomy and visibility
across the full product lifecycle, from late clinical stage through potential licensure.
Reach out directly for a confidential discussion:
#J-18808-Ljbffr