Regulatory Affairs Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000

Job Description:

We are seeking a highly motivated and detail-oriented professional to join our team as a Regulatory Affairs Specialist. The successful candidate will be responsible for preparing and submitting drug product submissions to Health Canada, ensuring accuracy and compliance with regulatory requirements.

Key Responsibilities:

  • Prepare and submit generic drug product submissions to Health Canada (e.g. NCs, SANDSs, DINAs), ensuring timely and accurate completion.

  • Evaluate change requests and prepare deficiency responses to Health Canada within given deadlines.

  • Review and contribute to implementation of post-approval changes of drug products.

  • Interpret scientific data and conclusions from CMC reports and summaries.

  • Collaborate with internal stakeholders and external partners to maintain project progress and ensure accountability.

  • Maintain a healthy working relationship with business partners and liaise with them to collect documents and information for submission preparation or in response to technical queries/deficiency letters from Regulatory Agencies.

  • Contribute to an efficient and effective regulatory affairs team and utilize knowledge and expertise towards a culture of continuous improvement.

Technical Skills:

  • Demonstrated oral and written communication skills, with the ability to communicate issues succinctly and logically.

  • Understanding of Health Canada and ICH regulatory guidance documents and policies.

  • Proficient computer skills, including MS Office applications and Adobe Acrobat; experience with eCTD publishing tools is an asset.

Leadership Skills:

  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

  • Ability to handle multiple priorities and balance work to achieve business goals.

  • Demonstrated effective communication and interpersonal skills on business commitments and project timelines.

Qualifications:

  • University Degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program.

  • Prefer a minimum of 2 years of experience in drug submissions for Canada, preferably with parenteral dosage forms.

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