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Regulatory Affairs Manager

Pharmanovia -
Mumbai, Maharashtra

Apply Now

Job details

Qualifications

Microsoft Powerpoint
Microsoft Outlook
English
Databases
Quality assurance
Bachelor's degree
Communication skills

Full job description

Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week)

About the Company

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally by revitalising niche, trusted medicines across our core therapeutic areas: Cardiovascular, Oncology, Endocrinology, and Neurology. Since our founding in 2013, we’ve grown consistently by delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers worldwide. Our global team of over 300 employees across 29 nationalities operates from offices in the UK, Denmark, the Netherlands, Switzerland, Italy, Spain, Germany, the UAE, India, Australia and Singapore.

About the Role

Our regulatory team provides strategic regulatory advice and life-cycle maintenance for the portfolio globally and supports new product development initiatives. This role reports directly to the Senior Manager, Regulatory Affairs.

Responsibilities

Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
Leads the preparation of core dossiers and submissions for global rollout.
Authors, reviews, and approve M3 dossier sections, justification documents, and Product Information as necessary.
In collaboration with global partners, consultancies, and distributors, we outline global regulatory intelligence and develop a global regulatory strategy.
In collaboration with senior management and project strategy teams, develops and reviews global cross-functional regulatory strategies.
Ensures diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting.
Negotiates and makes agreements on behalf of the department.
Interprets applicable regulations and guidelines for the project team’s use.
Keeps the project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans.
Serves as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions.
Facilitates communication between the HA(s) and the project team.
Attends and generally leads agency meetings, if required.
Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
Proactively identifies project issues to the project team and supports mitigation plans.
Attends cross-functional, vendor, and kick-off meetings as required.
Mentors and/or manages other Regulatory Managers, Regulatory Associates and other junior-level or administrative Regulatory staff.

Qualifications

Bachelor’s degree in a scientific/health field.

Required Skills

Excellent IT skills across all MS packages, including Excel, Word, PowerPoint, Project, Outlook, and Teams.
Experience in compliance and maintenance of product life cycle databases and RIM systems.
Strong knowledge of the EU regulatory framework and guidelines, and awareness of emerging markets submission rollouts.
Global regulatory strategy and deployment decisions, defining strategic priorities.
Expertise in regulatory submission structure and content (e.g. MAA, NDA).
Expertise in writing scientific and technical documents, and strong attention to detail in composing and proofing materials.
Ability to independently present complex global regulatory strategies internally and to Atnahs’ partners.
Ability to communicate comfortably and effectively with regulatory authorities.
Ability to work independently, resolve problems, take initiative and schedule and complete tasks to deadlines.
Ability to work successfully across cross-functional teams and environments.
Enjoyment of working in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Ability to build strong professional relationships.
Excellent professional English communication skills, both written and verbal

Preferred Skills

At least five years of relevant experience within a pharmaceutical company, CRO, CMO or similar organisation, with generalist regulatory knowledge.

Pay range and compensation package

We offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid working.

Equal Opportunity Statement

Pharmanovia is an equal-opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Pharmanovia will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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