Regulatory Manager - Pharma/OTC

Regulatory Manager

EXPERIENCE :

- Overall 10 plus year with a minimum of 5-8 years' work experience in managing Medical Regulatory affairs in Pharma / Consumer / OTC industry industry

- Well versed with Regulations - DNC Act, DPCO, ASCI, UCPMP, FSSAI , Ayush

- Communication & interpersonal skill

- Analytical & Critical thinking ability

- Leadership skills

- Set up and drive business strategy and processes

- Develop and execute Medreg (Medical Regulatory) strategy and annual operating plan

- Develop tracking mechanisms to gather intelligence on medical and regulatory trends.

- Analyze and Disseminate this information to help further business strategy

- Liaise with internal stakeholders to ensure OTIF delivery of projects Develop processes for exports, product registrations where required

- Developing SOP, specs, success KRAs and tracking of effectiveness / compliance of stakeholders to med regulatory norms

- Work with Capability Manager to develop requisite content, deployment and tracking mechanism to significantly raise the bar of competencies of the team

- Maintain agile, efficient and competent MedReg (Medical Regulatory) infrastructure

- Ensure compliance with regulations and SOP

- Ensure high scientific quality, regulatory compliance for product, marketing communications, packaging material

- Aid in acquisition work with respect to due diligence

- Resolution of queries/complaints

- Responding to queries, along with relevant scientific support from Internal / External customers

- Collating all important queries and sending to the Customer Care and marketing as FAQs Addressing technical queries on product positioning, competitor

- Aid in all resolution of all regulatory-related matters with ensuring minimal impact to business sales and maximum compliance to regulation.

- New product ideation and evaluation

- Identify new areas in which business can develop new products Initial research & discussions with Marketing team