Manager Regulatory Affairs | Pfizer | Vizag

Job Description

Manager – Regulatory, CMC Strategy, SI LCM

The Position:

You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite the approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in the development of the submission of product registration, progress reports, supplements, amendments, and periodic experience reports.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

Responsibilities:

• Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
• Assist in developing and implementing the regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defense, and regulatory compliance.
• Execute, through the use of standards and tools, designated operational tasks, or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.

Qualifications

Must-Have

• Master’s Degree
• 7+ years of experience
• Industry experience in Regulatory Affairs and/or Clinical Trial Management
• Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation
• Proven ability to consistently deliver to time, cost, and quality standards
• Strong problem-solving skills and team orientation
• Excellent written and verbal communication skills
• Good knowledge of Windows and Microsoft Office

Nice-to-Have

• Master’s degree
• Relevant pharmaceutical experience
• Awareness of and ideally experience in successfully communicating with Health Authorities
• Familiarity with pharmaceutical organizational structures, systems, and culture