Manager CMC Regulatory Affairs

BioSpace; Hyderabad; Hybrid; INR 2,200,000 - 4,200,000; Full time

Benefits offered by this job

Health insurance

Performance bonus

Job summary

Regeneron is seeking a Manager CMC Regulatory Affairs to join the CMC Regulatory Affairs team in Hyderabad. The role involves overseeing the regulatory submission form process and collaborating with cross-functional teams to enable the release of investigational product for clinical trials.

You will lead complex regulatory issues, develop submission justifications, and communicate strategy to management while mentoring a team in a fast-growing, science-driven environment.

Qualifications

• BS/BA in Chemistry, Biology, or related field (advanced degree preferred).
• Minimum of 79 years of experience working in the biopharmaceutical manufacturing or related industry, including regulatory or compliance related activities.
• Minimum of 2 years of leadership and/or managerial experience.
• Strong compliance background preferred.
• Experience in program management a plus.
• Ability to build collaboration and teamwork across cross-functional teams.
• Ability to work in an ambiguous environment and produce maximum results with minimum direction and guidance.
• Demonstrated history of building and maintaining positive relationships both internally and externally.
• Strong communication and negotiation skills.
• Open and receptive to change, while continually looking for opportunities to improve processes.
• Strong understanding of quality principles in a regulated manufacturing environment is helpful.

Responsibilities

• Contribute to the management of the regulatory submission form process, which involves reviewing documentation submitted to global health authorities to support the release of lots to clinical trials.
• Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.
• Lead meetings and presentations on more complex regulatory issues and participate in creating regulatory justifications.
• Keep management and all stakeholders informed of assessments, overall strategy, and project status.
• Contribute to training programs, metrics, and invoice approvals.
• Act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure submissions appropriately support the release of IP.
• Manage and lead a team.

Skills

Leadership

Regulatory affairs

Cross-functional collaboration

Program management

Communication skills

Education

BS/BA in Chemistry, Biology, or related field

Job description

Job Description:

Build Our Future Together

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager CMC Regulatory Affairs to join our CMC Regulatory Affairs team. In this role, you will interpret the current, approved, and planned clinical regulatory landscape by contributing to the management of the regulatory submission form process supporting the review of documentation submitted to global health authorities to enable the release of lots to clinical trials. You will collaborate across cross-functional teams while managing a team of your own, ensuring submissions appropriately support the release of investigational product. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

Hyderabad, India (hybrid)

Discover Your Role

Contribute to the management of the regulatory submission form process, which involves reviewing documentation submitted to global health authorities to support the release of lots to clinical trials.

Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.

Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials, ensuring timely communication between IOPS and global development.

Participate in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.

Lead meetings and presentations on more complex regulatory issues and participate in creating regulatory justifications.

Keep management and all stakeholders informed of assessments, overall strategy, and project status.

Contribute to training programs, metrics, and invoice approvals.

Act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure submissions appropriately support the release of IP.

Manage and lead a team.

This Role Requires

• BS/BA in Chemistry, Biology, or a related field (advanced degree preferred).
• Minimum of 79 years of experience working in the biopharmaceutical manufacturing or related industry, including experience in regulatory or compliance related activities.
• Minimum of 2 years of leadership and/or managerial experience.
• Strong compliance background preferred.
• Experience in program management a plus.
• Ability to build collaboration and teamwork across cross-functional teams.
• Ability to work in an ambiguous environment and produce maximum results with minimum direction and guidance.
• Demonstrated history of building and maintaining positive relationships both internally and externally.
• Strong communication and negotiation skills.
• Open and receptive to change, while continually looking for opportunities to improve processes.
• Strong understanding of quality principles in a regulated manufacturing environment is helpful.

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.