Associate Ii

1 week ago

Chennai Tamil Nadu, India Pfizer Full time

Responsibility:

- Functions as Support to Product Lead for Life Cycle Management (LCM),
- working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries.
- Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections for post approval submission.
- Responsible for effective coordination with the cross functional teams, site and Global RA teams for review.
- Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (Batch records, Exhibit batch and stability protocol).
- Provides regulatory assessment and support the Change Control Assessment with mínimal guidance.
- To ensure commitments (module 2-5) made to Health Authorities are entered into tracking systems and are fulfilled to closure, as appropriate.
- Participate and provide inputs in technical reviews and Change Control reviews as assigned.
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
- Remains updated about current regulations and guidance interprets and implements in the assigned projects.
- Responsible for ensuring compliance to organization submission standards, policies and procedures.

Qualification:

- Preferred Education:
Bachelors or Master in Science / Pharmacy
- Preferred Experience:
Minimum 4-6 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling new submissions / post approval changes to health authorities especially of US and EU. Experience in filing Sterile Injectables submission is preferable.
- Preferred Attributes:
Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Well-organized and accustomed to maintaining excellent records.

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.

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