Job for Senior Manager - Regulatory Affairs at MSD

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Post: Sr. Manager- Regulatory CMC

Job 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.

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..

Qualifications
• 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: B.Sc, B.Pharm
Location: Mumbai
Last Date: 20^th January, 2018