Senior Specialist

3+ years

Not Disclosed

Bangalore

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: MSc./M. Pharm/PhD 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: Regulatory Project Manager

Location: Electronic City Phase 1, Bangalore

About the Company:

At our company, we are committed to breaking barriers, exploring new possibilities, and discovering more. Our global team is dedicated to innovating with science and technology to improve lives in healthcare, life sciences, and electronics. We are always looking for curious minds eager to imagine the unimaginable and work with us to create solutions that enrich people’s lives, care for our customers, patients, and the planet. Join us to be part of a passionate team driving human progress!

Your Role:

As a Regulatory Project Manager, you will be responsible for global regulatory planning and tracking of regulatory deliverables for moderate-to-highly complex submissions to health authorities worldwide. You will manage the operational aspects of products with moderate to higher lifecycle maintenance activities. Working within a matrix organization, this role requires extensive collaboration and communication with various stakeholders to ensure efficient resourcing, smooth operations, and alignment with business priorities.

Key Responsibilities:

Project Planning: Create project plans for initial CTA/IND, MAA/NDA/BLA submissions, and significant regulatory submissions (e.g., HA meetings, Scientific Advice).
Collaboration: Work closely with the Global Regulatory Lead (GRL) and Regulatory Affairs Manager to provide submission strategies and collaborate with Submission Managers for execution.
Submission Execution: Oversee the orchestration and execution of regulatory submissions to health authorities, ensuring that all relevant information is provided to Submission Managers for planning and execution.
Crisis Management: Address and resolve issues impacting project timelines, including the creation of risk registers and maintaining oversight on regulatory risks.
Submission Taskforce Leadership: Lead and manage the Submission Task Force, ensuring the appropriate submission package and addressing interdependencies, risks, and issues.
Budget Management: Consolidate and track the regulatory project budget, collaborating with global project management and project controllers to ensure proper cost tracking (e.g., consultants, HA fees).
Scenario Planning: Assess global regulatory resource and budget demands for various projects, including deal-related activities (e.g., asset transfer after licensing).
Tool Management: Develop, manage, and improve project management tools and templates to ensure compliance with health authority requirements.
Regulatory Expertise: Possess a thorough knowledge of regulatory affairs, particularly for post-approval changes, dossier types, and regulatory procedures globally.

Who You Are:

Experience: 8-14 years of experience in a pharmaceutical environment, competent authority, or academia/R&D related to regulatory affairs.
Regulatory Project Management Experience: A minimum of 6-8 years of experience in regulatory affairs or as a regulatory project manager.
Education: A degree in Life Sciences, Medical, PharmD, or related discipline (minimum MSc or equivalent). Higher degrees (e.g., PhD) and advanced training in project management are a strong advantage.
Skills:
- Strong leadership and project management skills, especially in managing global regulatory submissions and complex project timelines.
- Expertise in regulatory processes and life cycle management for pharmaceutical products, including knowledge of required documents for registration (e.g., GMP certificates, PoAs, etc.).
- Proficiency with RIM and EDMS RA applications.
- Strong written and spoken communication skills in English.
- Ability to work effectively in teams and lead cross-functional collaboration.
- Excellent result orientation and a customer-focused mindset.
- Strong crisis management, risk management, and budget planning abilities.

What We Offer:

We are an equal opportunity employer, committed to fostering a diverse and inclusive workplace where everyone can bring their best self to work. Our company celebrates diversity in all its forms and believes it drives excellence, innovation, and creativity. We offer opportunities for personal and professional growth, encouraging you to develop at your own pace in a supportive and collaborative environment.

Join us and work on cutting-edge solutions that impact millions. Help us build a culture of inclusion and belonging that empowers everyone to achieve their best and drive human progress.

Apply Now:

Ready to explore, innovate, and grow with us? Apply today to join our diverse team and make a lasting impact in the world of regulatory affairs and beyond!

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Senior Specialist

Job Description

About the Company:

Your Role:

Key Responsibilities:

Who You Are:

What We Offer:

Apply Now:

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