People Lead - Regulatory Capabilities

Lifelancer; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Lifelancer is seeking a People Lead - Regulatory Capabilities in Hyderabad. This role requires leading regulatory lifecycle management, fostering an agile team culture, and managing a broad portfolio of assets. Candidates should have 7+ years in Regulatory Affairs within pharmaceuticals or biotechnology, a Bachelor's in a relevant field, and preferably a Master's or certification in Regulatory Affairs. Excellent interpersonal skills and the ability to develop people are essential.

Qualifications

• 7+ years of experience in the pharmaceutical/biotechnology industry, specifically within Regulatory Affairs.
• Deep understanding of CMC strategy for original submissions and post‑approval variations.
• Solid understanding of drug development and GxP/GCP/ICH guidelines.

Responsibilities

• Lead regulatory lifecycle management including NDA, ANDA, BLA, and MAA filings.
• Manage the regulatory strategy for a broad portfolio of assets.
• Develop trusting relationships and foster an agile team culture.

Skills

Regulatory Expertise

Operational Excellence

eCTD & Content Strategy

Compliance & Risk Management

Project Planning

People Leadership

Interpersonal Skills

Education

Bachelor's degree in Life Sciences, Pharma, Clinical Research or equivalent

Master's degree (preferably)

Certification or PG Diploma in Regulatory affairs

Tools

Veeva Vault

eCTD software

gSuite

Job description

Job Title: People Lead - Regulatory Capabilities

Job Location: 9F6G+9F9, Charminar Rd, Chowk Mohammed Khan, Chow Mohalla, Pathar Gatti, Hyderabad, Telangana 500002, India

Job Location Type: On‑site

Job Contract Type: Full-time

Job Seniority Level: Mid‑Senior level

Position Overview

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Key Responsibilities & Expertise

• Regulatory Expertise & Operational Excellence
• Global Regulatory Lifecycle Management: Deep expertise in leading the compilation and submission of NDA, ANDA, BLA, and MAA filings. You must have a proven track record of managing original submissions and post-approval changes across major markets (FDA, EMA, etc.)
• eCTD & Content Strategy: Advanced knowledge of eCTD format requirements and a high‑level mastery of Quality Overall Summaries (QOS) and CMC sections to ensure dossiers are "deficiency‑free."
• Regulatory Tech‑Innovation: Proven experience in advocating for and implementing Automation and Innovation initiatives including AI‑enabled solutions. You should be comfortable partnering with IT/Tech teams to move toward data‑driven, tech‑enabled transformation initiatives for the regulatory landscape
• Compliance & Risk: Demonstrated ability to apply GVP/GCP compliance and data integrity standards using a balanced, risk‑based approach rather than a purely "check-box" mentality
• Proven track record in preparing for and addressing audit findings, including oversight of Corrective and Preventive Actions (CAPA) and development of remediation strategies
• Strategic Thoughtpartner
• Ability to partner with leads from various PD functions to set and execute the regulatory strategy for a broad portfolio of assets, ensuring alignment with global health authority interactions
• Expert administrative and project planning skills, with the ability to manage resource allocation, project prioritization, and high‑pressure deadlines under minimal supervision
• Act as a strategic consultant to the PDR Community, providing high‑quality analytics, insights and recommendations that influence the broader Product Development (PD) division
• A self‑starter with an innovative mindset who doesn't just identify regulatory hurdles but actively solves business problems to support
• People Leader
• Ability to operate within the Roche framework as a Visionary, Architect, Catalyst, and Coach (VACC Framework). You will be required to spend roughly 30% of your time purely on people development
• Natural passion for people leadership with a track record of coaching and mentoring team members. You focus on building trusting relationships, removing barriers, and fostering an agile, empowered team culture, ensuring a pipeline of future regulatory leaders within the affiliate/region
• Highly skilled at building trusting relationships with various internal and external stakeholders, and ability to collaborate across various teams

Who you are

• You hold a bachelor's degree in Life Sciences, Pharma, Clinical Research or equivalent and 7+ years of experience in the pharmaceutical/biotechnology industry, specifically within Regulatory Affairs and Product Development. Preferably, you have a Master's degree
• Certification or PG Diploma in Regulatory affairs course is highly recommended
• Proven expertise in managing the eCTD lifecycle and a deep understanding of CMC strategy for original submissions (NDA/BLA/MAA) and post‑approval variations
• Solid understanding of drug development and GxP/GCP/ICH guidelines, combined with high proficiency in digital tools (Veeva Vault, eCTD software, gSuite) to drive automation and process improvements
• Excellent interpersonal skills with the ability to navigate complex matrix environments. You are a thought partner who can influence senior stakeholders and collaborate with Allied teams (QA, Medical & Regulatory Writing, etc.)
• A highly motivated, detail‑oriented professional who is learning‑oriented and committed to delivering deficiency‑free regulatory documentation in a fast‑paced environment

Roche is an Equal Opportunity Employer.