Senior Regulatory Manager
- India - Delhi
Job Summary:
Lead, manage and provide strategic direction to their regulatory team in assigned markets.
Manage assigned projects at a cluster level; provide strategic regulatory input into cross-functional product teams for pre- and post-authorisation product lifecycle activities working with above country operational hubs on operational activities.
Oversee strategy related to obtaining, managing and maintaining product Marketing Authorisations and support Clinical Trial Authorisations in line with business goals and legal requirements in partnership with above-country operational hubs. Conduct associated strategic regulatory activities for assigned products and markets and contribute to the implementation and leadership of projects and building expertise within the cluster regulatory team.
Job Responsibilities:
Cluster & Project Management
Responsible for identifying, implementing and managing key regulatory cluster/country projects either on an individual basis or as part of the Cluster leadership Team, to meet cluster regulatory objectives, including agreeing priorities with Head of Regulatory Sciences for the cluster/country as appropriate.
Leading role implementing effective and efficient processes in the cluster/country.
Monitor regulatory activities across product therapy areas and assist with the management of projects as necessary to ensure compliance with regulatory authority and corporate requirements and timelines.
Deputise for Head of Regulatory Sciences for the cluster/country as required.
People and Resource Management
Manage performance of direct reports to achieve agreed objectives, with high quality outputs, and to identify and address training and development needs.
Ensure regulatory team members work effectively in a productive and well-motivated environment through providing ongoing coaching, guidance and sharing of regulatory expertise.
Ensure direct reports are supported and that direct reports have a manageable workload through redistribution, prioritization or outsourcing of work, as necessary including planning of appropriate timelines and resource allocation. Include consideration of individual strengths when allocated project/product responsibilities.
Participate in the recruitment of new staff as required.
Ensures that all regulatory activities in the team are managed in compliance with Pfizer standards and international/local regulations.
Deliver Regulatory Strategy and Advise Cross-Functional Teams
In line with assigned product and country responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
Represent Regulatory on cross-functional product teams and provide strategic regulatory input to the commercial operating planning process.
Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate, including ensuring teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
Work with above country regulatory strategists to provide country specific input into Global and Regional regulatory strategies as required.
Ensure alignment of local and regional regulatory strategy and tactics.
Provide Regulatory Advice and Information to meet Customer and cross-divisional colleague requests.
Use expert knowledge of national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers.
Advise on matters of compliance, regulatory requirements and Pfizer regulatory policy.
Use a variety of communication tools and techniques to present complex ideas.
Anticipate potential objections and influence others.
Manage New Registration/Marketing Authorisation Applications:
National Applications
Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements, such as Scientific Advice Meetings.
Devise and obtain endorsement for submission strategy and plan and partner with above-country operational hubs and above-country strategists to obtain new product licenses. Manage associated interactions and negotiations with NRAs.
Manage Marketing Authorisation (MA) Variation Applications
Trigger locally driven submission demands (e.g. NRA queries and requests for local label updates).
Input to assessing regulatory impact, agree filing strategy with other business functions as appropriate and participate in risk-based reviews with above-country hubs and communicate any locally triggered delays & risks impacting the submission/approval, to the above and in-country stakeholders.
Work with above-country strategists and above-country operational hubs to supply country documentation/information for dossier build as applicable.
Communicate NRA decisions to relevant internal stakeholders as applicable.
Manage MA Renewal Applications
Agree filing strategy with relevant stakeholders as appropriate and participate in risk-based reviews of plans with above country hubs.
Management of NRA queries
In partnership with above-country operational hubs and above-country strategists, respond to NRA queries,
trade associations.
Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
Utilise local knowledge of NRA’s expectations, ways of working etc to appropriately direct company strategy. Share updates and regulatory intelligence with colleagues.
Seek authority advice/clarification if regulatory position is unclear and answers are not available through internal network.
Respond to spontaneous requests from authorities promptly and accurately.
Work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients.
Clinical Trials
Support, and ensure their team supports the following strategic clinical development activities in partnership with national Regulatory Authorities, Above Country Regulatory Strategists and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable:
Optimization of Clinical Development Plan (CDP) and Country Footprint.
Communications with NRAs to clarify questions during assessment as required by CTRSE
Support Regulatory Requirements Manager (RRM) updates for local Clinical Trial Applications (CTAs) and study conduct requirements.
Participation in national CTA Trade Association working groups and advocacy activities.
Populate and Maintain Regulatory Databases
Perform database entry and the document management for regulatory transactions undertaken by Country Strategists, in line with global SOPs.
Obtain NRA Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
Following a request from a prescriber and internal approval to proceed with supply of unlicensed Pfizer medicines to address unmet patient needs, facilitate NRA approval for supply/import via above country execution hub.
Safeguard Compliance and Manage Packaging and Prescribing Information Component updates
Via defined procedures notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information and the timelines for associated implementation activities.
Negotiate extensions to packaging artwork implementation with Regulatory Authorities when applicable.
Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity
Working with local stakeholders and above country operational Hubs, where applicable:
Divestments: Advise business on regulatory activities required prior to divestment/transfer of licence. Support licence transfer.
Discontinuations: Liaise with local Commercial/Medical/Demand functions and advise on regulatory action required for discontinuation of a product in the country marketplace.
Upon receipt of above-county endorsement to proceed, trigger applicable notification to NRA and other external stakeholders as required by national regulations.
Cancellations: Upon receipt of in and above-county endorsement to proceed, manage applicable notification/request to NRA, as required by national regulations.
Notify relevant colleagues of approval of the licence cancellation.
Interruptions to Supply: Notify NRAs of interruptions to supply in accord with national regulations and as agreed with cross functional team.
Work with cross functional team to explore options to help minimise or mitigate the out of stock. Obtain the necessary NRA approval as required and partner with above-country Operational Hubs as applicable.
Support Third Party Licences
Manage relevant, local regulatory activities related to supporting third party licences for which Pfizer has a contractual obligation, in accord with applicable business agreements and Pfizer SOPs.
Devices
Support regulatory activities for the development and maintenance of medical devices if required.
Contribute to Good Regulatory Practice (GRP)
Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained.
Help identify changes to business processes to improve them as necessary, including to reflect the changes in regulations.
Lead by example in relation to best practice and required procedures.
Through maintenance of regulatory activities in line with company procedures, contribute to “inspection ready” state.
Lead Personal & Team Development
Identify own training and development needs in discussion with Manager to ensure a broadening skill and knowledge base and to maximise/optimise career development and contribution to the business.
Develop product and therapeutic area knowledge as needed, according to product responsibilities list.
With support of Manager build on competency strengths and address development areas
Support personal development plans for direct reports.
QUALIFICATIONS / SKILLS:
Life sciences or chemistry graduate to honors level or equivalent
Master’s Degree, Post Graduate Diploma or PhD preferred
Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory)
Previous experience and proven track record in Regulatory (Human Medicinal Products)
Previous experience and demonstrated line management capability and/or experience of coaching and mentoring
Computer literacy
Excellent written and verbal communication skills
Proven strength in analytical thinking
Leadership capability
External:
National Regulatory Authorities (NRAs) – CDSCO, SFDA,
Trade association(s) OPPI, ISCR, IFPMA,, EFPIA
Other local country national bodies – DBT, ICMR, BIRAC
Internal:
Commercial
Medical
Access and Value
Quality
Regulatory Law
Regulatory International Operations
Global CMC
GILA
PGS
Global and International Regulatory Policy
Legal
Finance
Regulatory team comprising colleagues and/or contractors in the assigned markets in South Asia Cluster including India, Nepal, Bangladesh, Myanmar, Cambodia, Bhutan, Sri Lanka etc.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)