Urgent Requirement For Regulatory Affairs Manager

Deccan Nutraceuticals Pvt Ltd

key responsibilities:

strategic leadership: develop and implement regulatory strategies for new and existing products, ensuring alignment with company objectives and global regulatory requirements.

submission management: prepare, review, and submit high-quality regulatory dossiers to regulatory agencies (., fda, ema) for product registrations, variations, and renewals.

compliance assurance: monitor and interpret evolving regulations, guidelines, and standards to ensure ongoing compliance and proactively address potential risks.

collaboration & communication: collaborate effectively with cross-functional teams (r&d, quality, manufacturing) to provide regulatory guidance and support throughout the product lifecycle.

requirements:

regulatory expertise: in-depth knowledge of global pharmaceutical regulations, guidelines, and standards (., ich, gmp).

strategic thinking: ability to develop and implement effective regulatory strategies aligned with business objectives.

communication & collaboration: excellent written and verbal communication skills with the ability to build strong relationships with internal and external stakeholders.

problem-solving & decision-making: analytical and problem-solving skills with the ability to make sound decisions in a complex regulatory environment.

leadership & management: proven ability to lead and motivate a team, providing guidance and support to achieve departmental goals.

education required :

proven experience as a regulatory affairs manager in the pharmaceutical industry.

strong understanding of drug development and manufacturing processes.

excellent knowledge of regulatory submission requirements and procedures

• Experience

  9 - 12 Years

• No. of Openings

  1

• Education

  B.Sc, M.Sc

• Role

  Manager Regulatory Affairs

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office