Senior Manager, Regulatory Affairs (Biologics)

SUN PHARMA; Gurugram District; Hybrid; INR 1,800,000 - 3,200,000; Full time

Job summary

Sun Pharma is seeking a Senior Manager, Regulatory Affairs (Biologics) for a hybrid role in Gurgaon/Baroda/Mumbai. Lead CMC regulatory activities for US and advanced markets, ensuring lifecycle submissions and milestone delivery.

The candidate will drive regulatory strategy across complex projects, mentor junior team members, and collaborate with R&D, QA and manufacturing to ensure compliant, timely market supply.

Qualifications

• 10-15 years of hands-on experience in regulatory affairs.
• Proficient in English; additional language skills are a plus.
• Good inter-personnel skills with ability to direct multi-departmental functions.

Responsibilities

• Lead regulatory CMC product strategy for US, EU and Canada.
• Ensure lifecycle management through timely submissions of annual reports and supplements.
• Accountable for delivery of regulatory milestones for high-complexity products.
• Lead development and review of the CMC Regulatory Strategy Document for complex projects.
• Provide regulatory leadership in product in-license/due diligence and divestment.
• Manage CMC documentation including PIND/IND/CTA and NDA/MAA filings and health authority responses.
• Support new technology development.
• Demonstrate understanding of regulatory affairs to ensure continued market supply.

Skills

Regulatory leadership

CMC documentation

Technical writing

Cross-functional collaboration

Education

M-Pharm

Job description

Title: Senior Manager, Regulatory Affairs (Biologics)

Job Grade: G9

Work Setting: Hybrid (2-3 Days onsite per week)

Location: Gurgaon (preferable)/Baroda/Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.

Job Description

Job Responsibilities

• Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada
• Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity
• The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Manage execution of CMC documentation including PIND/IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Support new technology development within our Company.
• Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide.
• Conduct all activities with an unwavering focus on compliance.
• May need to manage or mentor junior team members.

Technical Skills

• Hands of expertise of preparation & review of dossiers, response to queries, communication with agencies for developed markets like US/EU
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
• Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.

Leadership Skills

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills.

Education Minimum Requirement: M-Pharm in pharmaceutical sciences

Required Experience And Skills

• 10-15 years of hands-on experience in regulatory affairs
• This role needs a seasoned professional who is aware of the regulatory activities for NDAs, can work in R & D CFT and who has the management capability of leading a group of team members
• The candidate must be proficient in English; additional language skills are a plus.
• Good inter-personnel skills with ability to direct multi-departmental functions.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).