Associate Director, Regulatory Affairs

15+ years

Preferred by Comapny

Bengaluru

10 Nov. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Clinical Trial Regulatory Lead

Key Responsibilities:

Clinical Trial Regulatory Submissions:
- Oversee clinical trial regulatory submissions with more than 15 years of relevant experience, ensuring compliance with regulatory requirements for global trials, particularly focusing on the European market.
Regulatory Leadership:
- Lead clinical trial studies and serve as the Regulatory Lead for global trials.
- Coordinate the preparation of regulatory submission documents and filings for clinical trials, working closely with teams to ensure all aspects of the trials are aligned with regulatory expectations.
Database Expertise:
- Demonstrate proficiency in handling the CTIS database and submitting European Union Clinical Trial Regulation (EU CTR) and CDSCO (Central Drugs Standard Control Organization) submissions.
Project Profitability:
- Monitor and manage the profitability of multiple projects/programs by collaborating with project leads to prepare and execute project plans, including managing budgets effectively.
- Proactively address potential issues with revenue recognition to ensure smooth financial operations.
Team Collaboration:
- Work both collaboratively within team environments and individually based on project needs to ensure successful completion of regulatory tasks and deliverables.
Mentorship:
- Mentor and provide guidance to project team members, helping to develop their regulatory expertise and achieve individual and team goals.
- Serve as a role model in maintaining high professional standards and regulatory compliance.
Issue Resolution:
- Lead issue and conflict resolution efforts within the project, ensuring smooth execution and alignment with project goals.
- Address challenges in project execution to mitigate risks and ensure successful regulatory submission.
Workload Management:
- Prioritize workload effectively, both for self and team members, to meet project scope and objectives while ensuring efficiency and deadlines are met.
Efficiency Improvement:
- Continuously identify and capitalize on opportunities to improve project efficiency, team performance, and regulatory outcomes.
- Take proactive steps to drive improvements in processes and results.
Performance Management:
- Actively manage performance of direct reports, including conducting performance reviews, salary actions, bonuses, and providing feedback.
- Hold team members accountable for key performance metrics and ensure they meet client expectations and project goals.
Staff Support:
- Provide support and input on staff management to appropriate project coordinators (PCs) to ensure optimal utilization and development.
- Facilitate staff development plans to improve expertise and skill sets.
Guidance and Accountability:
- Offer leadership and support to ensure staff meets key project metrics and goals.
- Provide clear guidance and hold staff accountable to ensure successful project outcomes.
Staff Development:
- Collaborate with Strategic Resourcing to provide opportunities for team members to expand their skills and gain further expertise.
- Ensure appropriate staffing levels to match expertise needs and project requirements.
Recognition and Reward:
- Reward staff for their contributions and accomplishments, ensuring they feel valued and motivated.
Leadership and Mentoring:
- Provide leadership, coaching, mentoring, and feedback to staff, helping them achieve both individual and team objectives.
- Foster a culture of quality, accuracy, and high performance.
Vision and Values Communication:
- Communicate and champion the organizational vision and values to ensure alignment with company goals.
Effective Communication:
- Facilitate clear and effective two-way communication with staff to ensure business updates, concerns, and interests are shared.
Consulting Services:
- Provide a full range of technical and/or business consulting services, particularly in areas where regulatory policy or precedent is clear.
Self-Development:
- Define self-development activities to remain up-to-date with industry trends and maintain membership in relevant industry and scientific/technical associations.
Project Efficiency:
- Improve project efficiency and outcomes through proactive measures, leveraging lessons from past projects and client work.
Information Leverage:
- Leverage insights and information from previous projects to complete current activities efficiently and facilitate informed business decisions.
Quality Work:
- Ensure that all work produced meets high-quality standards and client expectations. Review colleagues’ work to ensure consistency and alignment with regulatory and project goals.
Strategy Development:
- Develop strategies to address project issues, ensuring productivity, quality, and project goals are met.

Skills & Qualifications:

Experience: 15+ years of experience in clinical trial regulatory submissions, with leadership experience in global trials, especially within the EU market.
Database Expertise: Familiarity with the CTIS database and experience submitting EU CTR and CDSCO regulatory filings.
Project Management: Proven ability to manage multiple projects, ensuring profitability and timely completion.
Leadership: Strong mentoring and leadership capabilities, with a focus on team development and performance management.
Communication: Excellent communication skills, both written and verbal, with an ability to liaise effectively across teams and with clients.
Consulting Services: Experience providing technical and business consulting within regulatory affairs.
Regulatory Knowledge: Deep understanding of regulatory requirements, with the ability to guide teams in navigating complex regulatory environments.

Educational Requirements:

Degree: A degree in life sciences, pharmacy, or related field is required. Advanced certifications or higher education in regulatory affairs would be a plus.

This role is integral to ensuring high-quality, compliant regulatory submissions and successful leadership of clinical trial projects across various global markets.

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