Manager Reg Cmc Strategy
Year Chennai, Tamil Nadu, India
Job Description
b'
ob Summary:
- Serves as a CMC author & strategist for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and developing regulatory strategies.
- Acts as the global CMC representative within cross-functional project teams. Accountable for assigned projects and activities, completing work within assigned product portfolio. Develops resolution proposals for regulatory CMC issues with the stakeholders.
- Reviews proposed CMC changes for completeness and accuracy, interpret CMC regulatory requirements , develops strategies, assess risks and develops contingency proposals. Use technical and scientific knowledge to conduct the analysis of CMC submission documentation.
- Responsible for the authoring and review of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
Job Responsibilities:
- Serves as a as a CMC author & strategist for the development of CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting PBG\xe2\x80\x99s Business.
- Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities. Lead the preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans.
- Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
- Primary accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including post-approval changes, and ongoing compliance of commercial products in the portfolio.
- May represent CMC during interactions with internal and external partners either directly or in conjunction with Global Regulatory Affairs Teams.
- Resolve issues and manage regulatory risks within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
- Ensure compliance to Pfizer\'s training activities (e.g. functional, compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.
- Utilize Pfizer\xe2\x80\x99s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate
- Mentoring colleagues within focused area of expertise
Preferred Education:
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Minimum \xe2\x80\x93 Postgraduate in Pharmacy / Science
Preferred Experience:
Minimum 10 Years in Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes for Global market. Experience in filing of Oral Solid Dosage form and Sterile injectables submissions are preferable.
Preferred Attributes:
Excellent oral and written English communication skills. Strong project management and strategic problem solving skills. Sound interpersonal, collaborative and consensus-building skills, including diplomacy to negotiate conflicting priorities. An assertive, take-charge, proven manager with a strong results orientation, positive \xe2\x80\x9ccan do\xe2\x80\x9d attitude, and a sense of urgency to get things done. Well-organized and accustomed to maintaining excellent records.
Technical Skills:
- Sound knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance.
- Sufficient level of knowledge in handling post approval changes of Solid Oral Dosage forms and/or sterile injectable manufacturing and regulatory data requirements for managing Global post approval submissions.
- Knowledge in retrieving information from company\xe2\x80\x99s and regulatory agency databases.
- Good level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
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Job Detail
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Job IdJD3046811
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationChennai, Tamil Nadu, India
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EducationNot mentioned
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ExperienceYear