Senior General Manager - Regulatory Affairs - Pharma - PhD

One of our leading pharmaceutical, biotechnology client looking to hire Senior General Manager- Regulatory Affairs for Bangalore.

Designation: Senior General Manager- Regulatory Affairs

Job Location: Bangalore

Department: Quality Assurance

About Company:

It is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world.

JOB PURPOSE:

- To ensure the filing of required regulatory documents on time as per regulatory norms.

- Take active participation from initiation of the projects and provide Regulatory strategy inputs to the team and the clients.

- Liaise with Regulatory agencies, partners, customers, agents as appropriate.

- Take lead for execution of regulatory submission documents for project and be the lead of any Regulatory discussion with the agencies or clients.

- Review dossiers, regulatory documents, response to deficiencies as per the business needs.

Key Responsibilities:

- Head Regulatory Affairs shall be responsible for supporting all regulatory activities associated with product development, new registrations and lifecycle management as per requests from clients for:

- Development and scale up as well as production of small molecules, advanced intermediates and NCEs for molecules in early and late phase, as well as for commercial supplies.

- Pre-formulation studies, toxicology formulation, formulation development, analytical development and manufacturing of clinical batches under cGMP environment.

- Biologics/ Large Molecule Development and commercialization for microbial and mammalian productions including manufacturing from cell line and process development through large-scale production and supply of animal studies, clinical trial and commercial material.

- Review of plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc. Provide responses to regulatory agencies regarding product information or issues. Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices.

- Interface with Clients, key business and cross-functional stakeholders to ensure review of proposal for submission, review of infrastructure, process, resources, IT and systems for on time delivery of the project, submission planning, creation of submission documentation, submission requirements, product/facility change management, process support.

- Actively participate in CMC IND, ANDA content development as per project schedule. Analyze any changes in the requirements and implement changes in the database

- Accountable for the relationship with the US Food and Drug Administration, EMA, PMDA, MHRA, Drug control of India and other relevant regulatory bodies or govt agencies for regulatory submissions or sourcing purpose. To act as primary contact with US FDA and EMA and other regulatory agencies for activities related to product development or compliance.

- Create It s global regulatory strategies including risk strategies and execute submissions for development or sustaining projects and participate or lead regulatory forums with clients as per requirement.

- Ensure appropriate standards and content requirements are met for regulatory submissions

- Lead strategy development and actively participate for responding to Health authority queries, audits/inspections.

- Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers as required to meet changes in internal systems, changes in regulatory guidelines. Should maintain all hard and soft copies and database inappropriate template/ format as deemed necessary for all submissions.

- Responsible for review of impact of any changes to the client agreements and ensure the clients are appropriately informed about the changes and update the agreement accordingly if required.

- Should be constantly updated on any regulatory changes as relevant to the Company'sclients.

- Engage with Clients representatives to ensure regulatory activities are in alignment with the relevant regulatory requirements

- Possess the knowledge and exposure to environment, health, and safety (EHS) practices

- Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety

- Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team

Educational Qualification:

- Post graduate Degree: M. Pharm or M.Sc.

- Advanced Degree / PhD will be an advantage

- Experience in a healthcare environment is must with functional/specific competencies

Technical/functional Skills:

- Knowledge of regulations and ability to communicate and apply

- Should have rich experience interacting with FDA, EMA, MHRA, ANVISA, TGA, PMDA, DCI or other Govt agencies/ Authorities.

- Good written and verbal communication, presentation, and facilitation and negotiation skills.

- Ability to identify compliance risks and escalate when necessary

- Proficient in using electronic systems and tools as deemed necessary for regulatory purposes.

- Technical knowledge in API, Biologics and Finished dosage form, as well as knowledge on non-clinical, clinical and BA/BE studies with Labeling requirements, would be an advantage.

Experience:

Minimum of 15 years- experience in regulatory affairs handling multiple geographies.