Experienced Manager
RAC.GEN.M2
Regulatory Affairs Manager II / Senior Manager
Regulatory Affairs Manager II / Senior Manager
The story of this role
Who does this work
Regulatory Affairs Specialist at a CDMO who seeks to ensure that drug and biologics development processes are compliant with all relevant regulations while facilitating smooth regulatory submissions to health authorities.
The problem this role solves
- The external problem: Navigating complex and constantly changing regulations and guidelines in the pharmaceutical and biologics industry.
- The internal problem: Feeling overwhelmed by the pressure to ensure compliance and the fear of potential penalties or setbacks in drug approvals.
- Why it matters: Believing that patients deserve safe and effective therapies, and it's the responsibility of regulatory affairs to uphold these standards.
The plan
- Conduct thorough research on current regulations and guidelines relevant to drug and biologics development.
- Develop comprehensive regulatory submission strategies tailored for each product under development.
- Collaborate with cross-functional teams to gather necessary documentation and data for submissions.
- Prepare detailed regulatory submissions to health authorities, ensuring clarity and completeness.
- Provide ongoing support and updates to the team on regulatory changes and submission status.
What's at stake
Experiencing delays in product approvals due to incomplete or incorrect submissions. Facing penalties or rejections that can damage the CDMO's credibility and future business prospects.
Success looks like
Achieving timely approvals for drug/biologics submissions with minimal queries from health authorities. Establishing a reputation for the CDMO as a trusted partner in regulatory compliance, attracting more clients.
Summary
Regulatory Affairs Manager II / Senior Manager
Level — M2 — Manager II
Manages an established team or sub-function; owns planning and performance for the group.
- Scope
- An established team or sub-function
- Autonomy
- Owns planning for the group
- Complexity
- Cross-project coordination and priorities
- Impact
- Group delivery and development
- Decision rights
- Owns staffing, priorities, performance for the group
- Leadership
- Manages a team; sometimes manages leads
- Typical experience
- 5–8 yrs
Core outputs
No core outputs recorded yet.
Adjacent roles
Nearest roles by structural coordinates (level + taxonomy). Distance 0 → 1; each carries its 3-state match band. How coordinates work → · Compare side-by-side →
Componentsshow ▾
Responsibilities5
- Manages multiple projects or a larger program within the RA portfolio.commonlevel
- Develops regulatory plans for projects.commonlevel
- Serves as an RA point of contact for clients on assigned projects.commonlevel
- Ensures that regulatory documentation systems are maintained for their projects.commonlevel
- Supervises M1-level RA staff or specialists.commonlevel
Tasks3
- Manage RA projectscommonlevel
- Develop regulatory planscommonlevel
- Supervise RA staffcommonlevel
Skills5
- Project managementcommonlevel
- Regulatory planningcommonlevel
- Client communicationcommonlevel
- Documentation managementcommonlevel
- Leadershipcommonlevel
Knowledge5
- Regulatory project managementcommonlevel
- Client relationship managementcommonlevel
- Documentation systemscommonlevel
- Regulatory strategiescommonlevel
- Team supervisioncommonlevel
competency5
- Leadership & People Managementcommonlevel
- Project managementcommonlevel
- Regulatory Judgementcommonlevel
- Negotiation & Influencecommonlevel
- Adaptabilitycommonlevel
qualification3
- Bachelor’s degree in a relevant fieldcommonlevel
- 7–10 years of regulatory affairs experiencecommonlevel
- Master’s degree or RAC certification preferredcommonlevel
Title aliasesshow ▾
| Alias | Type | Confidence | Approved |
|---|---|---|---|
| Manager, Regulatory Affairs (CDMO) | common | medium0.66 | — |
| Regulatory Affairs (CDMO) Manager | common | medium0.60 | — |
| Experienced Manager | common | medium0.50 | — |
Classification mappingsshow ▾
O*NET / SOC
- code=11-9199.01title=Regulatory Affairs Managerssource=corpusreviewStatus=approved