At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering
an setting 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