DRA

The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools, systems.

The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.  Should keep the all the regulatory database up to date. Candidate must possess do it right the first-time approach with proven track record. 

Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries. Excellent written and spoken communication skills in English

As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval.

Seasoned experience in handling of various EU procedure like DCP, MRP, National. National phase handling for EU procedures. Post approval variation compilation and filling to various EU agencies

Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure as applicable

Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and, or regional perspective.

Regulatory Affairs professionals with 5 to 8 years of experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets.

Bachelors in Pharmacy or Masters in Chemistry, Sciences, Biotechnology ,Biomedical Engineering; Provide regulatory metrics on performance that are aligned with Area & GEM Regulatory Affairs criteria to measure regulatory performance to LOC, Area & Regional management