Job for Senior Manager- Regulatory CMC at MSD

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD’s Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.

Post : Sr. Manager- Regulatory CMC

Role Description
The candidate will be responsible for development of regional CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for all MSD products, serving as a link between with local Affiliate Drug Regulatory Affairs (DRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities.

The Regulatory CMC Regional Hub is a key component of MSD’s strategy to build regional regulatory knowledge, effective local relationships with MSD country offices in order to deliver appropriate regulatory strategies and right first time regulatory submissions and support conformance of MSD’s manufacturing practices with registered details.

Responsibilities:
The incumbent will be accountable for implementing regional CMC strategy for international markets for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions including the following activities:
• Coordination of regulatory change assessments from local countries within the region and documentation within CMC change management electronic systems
• Prioritization of execution of submissions as per global regulatory strategy and in coordination with local affiliates to ensure regulatory conformance.
• Seeking opportunities to maximize submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities.
• Tracking of submission and approvals, and ensuring bidirectional communication of status with local and global CMC teams.
• Preparation of submission documentation by modification and consolidation of global documentation for local submissions according to local/regional requirements, and in consultation with subject matter experts in global CMC and local countries.
• Preparation of timely responses to Health Authority questions resulting from post-approval or new product submissions in regional markets under responsibility.
• Ensuring submissions are prepared in alignment with Health Authority commitments as result of license/dossier approval.
• Representing regional CMC strategy on cross-functional teams to ensure mutual understanding of local/regional CMC requirements and program complexities, and maintaining close communication with regional and local Affiliate DRAs, regional Supply Chain teams, global CMC product leads and the Regulatory network.
• Ensuring awareness of regional regulatory policy trends and maintaining the regulatory intelligence repository for regional markets under responsibility.
• The candidate may be required to travel to other MSD sites on a periodic basis.

Candidate Profile
• The candidate must possess a degree in science with a minimum of 4 years of experience in the pharmaceutical industry.
• The ideal candidate will have experience in Regulatory Affairs for the regional markets, with a focus on Regulatory CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance.
• He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
• Must have a proven ability to communicate effectively in both a written and verbal format. The ideal candidate will be fluent in 1-2 languages spoken in the region of responsibility, in addition to English.
• Ability to influence and work both independently and collaboratively in a team structure.
• Proven ability to work well under pressure.

Additional Information:
Experience: 4 years
Qualification: Degree in science
Location: Mumbai
Last Date: 30^th January, 2018