At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.
Post : Senior Manager - Regulatory Affairs, EU
Job Description
The Senior Manager, Regulatory Affairs will drive a team of motivated regulatory professionals, taking accountability for end to end life cycle maintenance for Marketing Authorization’s (MA) held by ADVANZ PHARMA (or one of its Legal Entities) based on portfolio assigned with a focus on supply continuity and compliance.
• People management – Independently able to drive recruitments, Set objectives (SMART) for team, identify skillsets needed and drive training/development needs of team, encourage regular feedback sharing within team emphasizing on building a positive and motivating/appreciative culture within team but at the same time ensure constructive feedback where needed to build the right operational efficiency, Ensure active oversight on business KPIs – identifying negative trends and working on them promptly, demonstrate situational managerial skills (operational / delegative) based on business need, adept in driving performance management including having difficult conversations if needed due to poor performance, manage conflicts sensibly, work diligently in developing a deputy for the role and encourage team /participate by self in various regional /global initiatives
• Keeping a proactive approach in maintaining an effective oversight on all aspects of Life cycle maintenance of the Marketing Authorizations held by the company based on portfolio assigned (including annual retentions, renewals, variations (CMC, safety or administrative), Product Information updates, GMP pre-clearances/site registrations); ensure right planning and prioritization of work within the team, facilitating availability of documents / information necessary for teams to work, establish review mechanisms within team to achieve right first time submissions and ensuring an active oversight on agency correspondences ensuring prompt and adequate reply.
• Keep an active oversight of Class A/B molecules (based on product classification) from a stock continuity perspective and ensure right prioritization, timely escalations (to Unit Head/ Director within regulatory and any cross functional team that’s involved) if needed to avoid any business disruption
• Helping the team with strategic planning for submissions, focussing on right classification of variation with an emphasis on urgency of change, nature of change (compliance / general), optimising submission cost, timelines for approval and any risk assessment needed.
• Oversight and responsibility of approving documents in document management systems such as Trackwise, GLAMS, MyQUMAS, Regulatory Information Management System
• Provide input in connection with implementation of new systems, drive changes within team
• Able to independently project manage regulatory aspects (for the global team) of any complex cross functional project (which can be either compliance related or Continuous improvement or any other business change) as and when delegated.
• Build and oversee a robust mechanism to capture and disseminate regulatory intelligence across wider business (including global regulatory team) as and when needed, facilitate sharing of knowledge and identify the need for training / coaching of team/stakeholders on new /updated regulations and executing them
• Close working with key stakeholders including Commercial, Supply Chain, Quality, Medical, Drug Safety, Operations and Technical teams to ensure alignment on priority /timelines for any regulatory submission / approval / implementation in line with stock requirements.
• Work towards building good reputation within business/ with Health authorities by focussing on clarity on communication, customer responsiveness, cross functional collaboration and at the same time advocating the success stories of team and working out on any cross functional challenges the teams may face
• Participate (actively or through guidance/oversight) in continuous improvement initiatives
• Support and actively participate in preparation for any GMP/GVP inspection from regulatory authorities; if needed be able to participate during the inspection as well.
• Reporting responsibilities to leadership team as and when needed
• SOPs and WIs – Support team with inputs and work towards building simplification,
• Actively support Unit Head/ Director while executing Integration of a new product or company that’s acquired in the business
• Represent Unit Head in various operational and cross functional meetings as and when required with active participation providing regulatory guidance and strategic input.
• Thrive in an entrepreneurial environment and take accountability for results.
• Embrace challenge and change, applying a growth mindset approach.
• Have a bias for action and fast decision making.
• Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
• Drive the spirit of “One Team” by working collaboratively across all business functions with an open, honest, and respectful cooperation.
• Contribute to making ADVANZ PHARMA a desired place to work.
Candidate Profile
• Graduate in Pharmacy or Life Science related subject
• A Post graduate qualification in Pharmacy is desirable
• Significant Regulatory Affairs experience, working in an individual contributor life cycle maintenance role (CMC/Module1)
• Very good understanding of EU regulations, should be able to give professional guidance for the responsible geographies
• Demonstrable experience as an individual first hand contributor handling Life cycle maintenance (CMC/Module1)
• Strong knowledge of Regional regulatory guidelines / CTD/ ICH / eCTD
• Experience with Health Authority Interactions, including Inspections
• Line management experience, leading a team of 3 or more
• Commercial awareness of business and good understanding of cross functional dependency
• Experience working in a cross functional, and cross cultural environment
• Strong communication skills, including fluency in English (Verbal and Written)
• Excellent attention to detail
• A positive and ‘can-do’ approach, biased towards finding solutions and embracing change
• Inspired by our values of entrepreneurship, speed and integrity
• Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows
• Work collaboratively across all business functions with an open, honest, and respectful cooperation
Additional Information
Qualification : Graduate in Pharmacy or Life Science
Location : Andheri (East), IN, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th June 2024
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