Chief Manager - Regulatory Affairs - Peptide

A Regulatory Affairs (RA) Head is responsible in ensuring the company s peptide products comply with all relevant regulations. This position involves strategic oversight, regulatory submissions, compliance management, and liaison with regulatory authorities.

Auditors and Customers on need basis

• Leadership skills
• Ability to connect the dots in various situations, seeing the risk and keep the mitigation plans.
• Clear communication.
• Analytical mindset.
• Quick and effective decision making.
• Stakeholder management

• Planning and execution of RA activities.
• Managing and coordinating the continuous development and implementation of the regulatory department's strategy, to ensure it meets the business requirements and customer deliverables, as well ensuring the departmental performance against goals.
• Review of regulatory submission US, Europe , Canada & other regions.
• Response to queries from Regulatory agencies and Customers
• Evaluation of changes in pharmacopoeias with respect to API s manufactured and making necessary changes/ inclusion in related documents.
• Review of Pre-approval/ approval of change control, deviation and necessary QMS documents.
• Interaction with cross functional team members of Business development, QC, QA, Production and R&D on various commercial/technical issues required for completion of documents and responding to queries.
• Involvement in various day to day RA activities to implement up to date knowledge regarding guidelines and regulations through training.