Company: Global Pharma Company
Experience: 5+ Yrs
Job Location: Mumbai
Key Skills: Regulatory operations
Must Have Skills: Regulatory operations
Senior Manager - Regulatory Affairs
UG , PG
• Delivery on compliance in assuring and fulfilling the regulatory performances in India.
- Regulatory Operations:
• Lead and manage the local RA team members in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Ensure that local RA teams provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives.
• Develop strong partnerships with in-country (e.g. BU Leads, Medical, Marketing, Supply Chain) and WRS-EM Therapeutic Area and Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Provide strategic contribution to the country (PCO) leadership team – anticipate what WRS-EM needs to contribute to achieve business objectives.
• Responsible for the development, leadership and performance management of the local RA team to achieve company objectives. Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs.
• Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product. Develop a long-term and positive relationship characterized by integrity, quality, compliance and leadership. Act in the capacity as the main liaison and primary contact for local government regulators with regards to all regulatory affairs related activities.
• Active participation in local trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. 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.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems (e.g. CMC change control, product labelling, etc.) are in place, and that the local RA staff are properly trained in these systems and procedures.
• Oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established WRS-EM performance metrics.
• Responsible for ensuring that all regulatory activities (new product submissions, clinical trial applications, existing licenses, etc.) are compliant with local regulations, requirements and practices.
• Implement technology solutions for enabling better information availability.
• Demonstrate and promote Pfizer global value system across all interactions.
• Contribute to Pfizer’s quality-consciousness and research-based image.
• Delivery per country benchmarks.
Technical Skill Requirements:
CompetencyDetail / Comments (specific skills, etc.)
Knowledge of the India, Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.
Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. Experience in preparing and submitting CTA’s, NDA’s, variations and LC submissions. Working with and influencing, opinion leaders, external organizations and PCO’s facilitating approval of submissions. Is driven to continually enhance regulatory expertise, both locally and globally.
Knowledge of drug development practice, rules, regulations and guidelines.
Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans. Maintains internal and external networks to learn in advance about new regulatory trends or changes impacting the Regulatory, Medical and overall Business strategy.
Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.
Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.
Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. Has built a strong relationship with the local health agency and other relevant stakeholders (rKOL’s) and pro-actively manages issues with the HA’s and other key external stakeholders.
Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions
Understands Business and Financial Environment
Understands how role is impacted by and contributes to external business environment and financial drivers.
Understands Pharmaceutical Industry
Understands and develops mitigation strategies for issues and drivers impacting the Pharmaceutical industry. Understands the need for connectivity and active contribution to local trade industry groups, being a recognized regulatory professional partner, and the strategic importance of this information to the local business.
Qualifications (i.e., preferred education, experience, attributes)
• Scientific Degree. A higher degree (MS or PhD).
• Pharmacist degree is preferred with Masters .
• Appropriate regulatory experience in industry – minimum 8 – 10 years’ experience
• Management Degree (Undergraduate or MBA) may be an advantage.
To apply, send your updated resume to
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