Executive/Senior Executive, Regulatory Affairs CMC, Upjohn

Job Description

What You Will AchieveYou will represent Upjohn Pfizer as CMC Author/Strategist in the regulatory affairs team. Your understanding of regulatory procedures will help in development of submission of product registration, changes, variations, supplements, amendments and periodic annual reports.As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.How You Will Achieve It

• Responsible for the preparation and finalization of high quality Global Regulatory Strategy Documents (GRSD), CTD sections of supplements / variations for Lifecycle Management (LCM) submissions and ensure effective data presentation and quality, by self or under guidance.
• Contribute to the completion of project milestones and organize own work to meet project task deadlines.
• Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
• Provide regulatory support to the cross functional teams for the assigned products, participates and provides inputs in technical reviews and strategic discussions on regulatory submissions.
• Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
• Liaise with key stakeholders to ensure the filing strategies are defined and executed, and Board of Health (BoH) requirements are met, ensuring a submission ready dossier.
• Ensure commitments made to health authorities are entered into tracking systems and are tracked to closure.
• Manage continuous improvement of selected processes relating to submissions and selected projects and related activities.
• Maintain the required regulatory databases to ensure compliance.
• Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies.

ROLE RESPONSIBILITIESThe Executive/Senior Executive, Regulatory Affairs CMC, Upjohn is responsible for:

• Authoring and/or coordinating CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating & contributing to responses to Agency queries and performing quality review of regulatory CMC submissions
• Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC
• Help GRS-CMC complete the task by Prioritizing & completing assigned workload appropriately under minimum supervision.
• Reviews and applies pertinent global regulatory guidelines
• Develops technical justification of change for agency submission
• Presenting and articulating issues for resolution, communicating regularly with GRS-CMC to ensure alignment and Flags identified risks
• Utilizes Pfizer s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.
• Supports Query and/or commitment management in collaboration with GRS CMC
• Developing effective relationships with local & global internal partners, i.e., R&D, PGS, Country Regulatory Leads, other CMC lines.

QualificationsMust-Have

• Masters/Bachelors Degree in Pharmacy or equivalent
• 3-8 years of hands-on CMC authoring experience (initial registrations or post-approval variations).
• Advanced skills in written & oral communications are mandatory.
• Knowledge of the regulations and guidelines in the various markets
• Computer literacy and ability to learn new systems

Technical and/or other job-related skills

• Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP s required to assess technical, scientific & regulatory merits of CMC information, commitments and data.
• An understanding of regulatory requirements & expectations, criteria for submission & approval globally. Updates, interprets, and applies global & regional CMC guidelines.
• Ability to contribute to global regulatory strategies by proactively discussing with partners. Experience engaging in the external regulatory & pharmaceutical environment is preferred.
• Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
• May serve as Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains
• Emerging awareness of new scientific or manufacturing technology

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs #LI-PFE,

Keyskills :
competitor intelligenceproduct registrationcontinuous improvementcommercial activitiesregulatory requirementstechnical reviewsregulatory affairstracking systemsline extensionsdata presentation