MPharma Regulatory Affairs Manager Job at Pfizer, Apply Online
Manager, Regulatory Affairs
India – Mumbai
Time Type: Full time
Posted on: Posted Today
Job Requisition ID: 4905147
The PCO based colleague Manager is mainly responsible for end-to-end regulatory activities i.e. (Operational and Strategy) both as well support/ inputs for country businesses successful launch of local and imported products for assigned portfolio including Clinical Trial applications. He/she will work to ensure collaborative connectivity with the key stakeholders (e.g. Commercial, Medical, above country colleagues etc.), and share a focused regulatory approach to supporting country business objectives. He/she will support to India Agency regulatory lead for Nepal, Sri Lanka, Bhutan & Bangladesh for assigned products and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs) for Pfizer India.
Responsibilities
1. Strategic/Policy:
– Delivery on compliance in assuring and fulfilling all the regulatory processes for assigned portfolio both for local and imported products marketed for Pfizer India.
2. Operational:
Regulatory Operations –
- Delivery on compliance in assuring and fulfilling the regulatory performances in India and support to India Agency regulatory lead for Nepal, Sri Lanka, Bhutan & Bangladesh markets.
- – Provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives and in the development of regulatory strategies to support the registration of new products, line extensions, major variations and lifecycle management.
- – Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, etc.). Act in the capacity as the liaison and contact for local government regulators with regards to all regulatory affairs related activities.
- – Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies and decision making. Positively influence local legislative initiatives that could impact the business.
- – Approval and maintenance of all license and no adverse business impact due to lack of regulatory approvals.
- – Demonstrate and promote Pfizer global value system across all interactions.
- – Contribute to Pfizer’s quality-consciousness and research-based image.
- – Generate and meet customer expectations on regulatory support and deliverables.
- – Implement technology solutions for enabling better information availability.
Qualifications & Experience required
- – Minimum 5-10 years of relevant Regulatory Affairs experience.
- – Scientific Degree. A higher degree (M. Pharm) may be an advantage but is not essential.
- – Pharmacist degree preferred but not mandatory.
- – Management Degree (Undergraduate or MBA) may be an advantage.
- – Knowledge of pharmaceutical affairs regulations and regulatory process and environment
- – Negotiating, communication, interpersonal and presentation skills
- – Knowledge of the India regulatory environment and how this impacts regulatory strategy and implementation
- – Knowledge of drug development practice, rules, regulations and guidelines.
- – Understands business and financial environment
- – Understands Pharmaceutical Industry
- – Communication & Negotiation skills
- – Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
- – General management experience and previous line management and leadership experience at senior management level is essential
- – Proven ability to manage complex regulatory issues.
- – Proven ability to consistently deliver to time, cost and quality standards.
- – Demonstrable experience of effective delivery in a complex matrix environment
Link to apply: Apply Online
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