Regulatory Project Head

10+ years

Not Disclosed

Mumbai

10 March 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Project Head

Location: India - Mumbai
Category: Regulatory Affairs

Primary Job Function:

Independently handle regulatory product registrations, submissions, compliance, and strategy while coordinating with cross-functional teams and affiliates.

Responsibilities:

1. Product Registrations / Submissions

Lead and coordinate complex project registrations, including new product introductions.
Identify and collect necessary data, delegating tasks where appropriate.
Seek expert advice and technical support as needed.
Prepare responses to deficiency letters.

2. Relationships & Cross-Functional Teamwork

Represent Regulatory Affairs in relevant meetings and present the agreed RA position.
Provide expert advice and technical support to cross-functional colleagues.
Monitor actual versus planned activities and timelines.
Proactively identify, communicate, and mitigate project risks.

3. Affiliate Coordination

Maintain strong relationships with Regional Product Leads and Affiliate colleagues.
Identify and implement improvements in knowledge sharing and collaboration.

4. Compliance Across Life-Cycle

Assess and approve change requests, ensuring files are updated accordingly.
Maintain expert knowledge of legislation and regulatory developments.
Act as a subject matter expert.
Manage corrective action plans and ensure timely completion.

5. Strategy

Lead and coordinate regulatory product strategies for assigned products and projects.
Identify, communicate, and mitigate regulatory risks.

6. Process Improvement

Identify opportunities for process improvements and implement changes.
Develop position papers and work aids.

7. Health Agency Interaction

Take a leading role in preparing for and attending Health Agency meetings.
Act as a single point of contact for Notified Bodies and other regulatory organizations when required.

8. Licensing Reviews

Lead and coordinate regulatory due diligence activities for assigned projects.

9. Technical Competency

Maintain expert knowledge of global regulatory requirements.
Possess specialist regulatory knowledge across multiple countries and product classes.
Ensure regulatory knowledge remains current.

Core Competencies:

Anticipation

Develop scenario and contingency plans to achieve results under changing conditions.
Implement proactive changes to mitigate risks and improve processes.
Gather and act on customer inputs to anticipate and fulfill needs.

Adaptability

Prioritize and plan long-term work tasks effectively.
Identify synergies and opportunities across the organization.
React quickly to solve problems and re-prioritize as necessary.

Initiative

Understand organizational structures and cross-functional roles.
Anticipate and mitigate problems proactively.
Seek feedback from managers and team members to enhance performance.

Innovation

Identify and execute innovative solutions to work challenges.
Encourage experimentation and learning from failures.
Integrate information from multiple sources to develop new insights.

Integrity

Deliver high-quality results within deadlines.
Exhibit honesty, consistency, and impartiality in decision-making.

Teamwork

Utilize leadership skills to drive individual and shared goals.
Support and mentor colleagues to develop their skills.

Leadership Competencies:

Set Vision and Strategy

Use influencing and negotiation skills to align stakeholders.
Drive robust regulatory strategies for global projects.

Build Organization and Inspire People

Mentor junior team members and provide training.
Demonstrate and encourage strong leadership qualities.

Drive Results

Show persistence and energy to drive organizational goals.
Hold self and others accountable for commitments and results.

Make Difficult Decisions

Identify and appropriately escalate crisis situations.

Encourage an Open Environment & Knowledge Sharing

Provide frequent, constructive feedback to peers and subordinates.
Promote open communication and knowledge sharing.

Supervisory / Management Responsibilities:

Direct Reports: None (Individual Contributor)
Indirect Reports: None (Individual Contributor)

Education, Qualifications & Experience:

Education: Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field.
Experience: 10+ years in Regulatory Affairs, R&D, Manufacturing, or related areas.
- Exceptions may apply for candidates with a higher degree in a related discipline.

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