Job Summary**
The Senior Manager - Regulatory Affairs will lead and manage regulatory activities for assigned products and projects, ensuring compliance with Indian and South Asian regulations and strategic alignment with business objectives. This role also will support the Pharmacovigilance activities. This role requires a proactive and adaptive individual capable of driving regulatory strategy and fostering effective relationships with regulatory bodies.
Job Responsibilities**
* Develop, implement, and maintain global regulatory strategies for assigned products throughout their lifecycle.
* Lead and manage regulatory submissions, including initial applications, variations, renewals, and responses to agency queries, ensuring timely and high-quality deliverables.
* Oversee and manage change control processes related to regulatory documents and submissions.
* Act as the primary point of contact for interactions with regulatory agencies, fostering strong relationships and effective communication.
* Conduct continuous monitoring of regulatory landscapes to identify potential impacts and opportunities, adapting strategies accordingly.
* Ensure all regulatory activities adhere to established regulatory processes and internal standard operating procedures.
* Manage the full document lifecycle for regulatory dossiers, ensuring accuracy, completeness, and retrievability.
* Lead and participate in cross-functional project teams, providing expert regulatory guidance and ensuring project milestones are met.
* Identify, assess, and mitigate regulatory risks associated with product development and commercialization.
* Responsible for the development and maintenance of product labelling in compliance with relevant regulations.
* Communicate effectively with internal and external stakeholders, presenting complex regulatory information clearly and concisely.
* Plan and prioritize regulatory activities to meet deadlines and achieve strategic objectives.
* Champion a culture of continuous improvement and problem-solving within the regulatory team.
* Deliver consistent and high-quality results in all regulatory endeavors.
* Handle the Pharmacovigilance activities for India and South Asia
Job Qualifications**
* Master's degree in Pharmacy or a life science discipline or related field; advanced degree preferred.
* Minimum of 12+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
* Proven expertise in developing and executing regulatory strategies across various therapeutic areas and global regions.
* Demonstrated experience with regulatory submissions at CDSCO and State FDAs and interactions with health authorities.
* Strong understanding of Indian regulatory requirements and guidelines and also PvPI guidelines.
* * Proficiency in change control processes and document lifecycle management.
* Ability to think critically, solve complex problems, and adapt thinking and behavior to evolving regulatory environments.
* Exceptional communication, negotiation, and interpersonal skills.
* Proven ability to build and maintain strong regulatory relationships.
* Strong analytical skills with an aptitude for continuous monitoring and risk assessment.
* Highly organized with excellent planning and prioritization abilities.
