Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ensure consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management will also be valuable in this role. In addition to primary skills, deep understanding of CMC regulatory requirements for biologics/biosimilars and experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics are secondary skills required for this position. Ideally, you should possess a minimum of 8 years of experience in CMC-Biologics along with a Master's degree in pharmaceutical sciences or other life sciences. Your ability to work independently, manage multiple priorities in a fast-paced consulting environment, and attention to detail are crucial for success in this role. Experience with RIMS/Veeva Vault for submission management and regulatory compliance is preferred. At Syneos Health, we are dedicated to developing our employees through career progression, supportive line management, training programs, and a total rewards program. Our Total Self culture fosters an environment where authenticity is encouraged, and diversity of thoughts and perspectives are valued. Join us in our mission to accelerate the delivery of therapies and change lives. Learn more about Syneos Health and the impactful work we do across 110 countries with 29,000 employees.,

Posted 6 days ago

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Regulatory Affairs - Executive/Assistant Manager/Deputy Manager/Manager Viatris

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As an experienced professional in the pharmaceutical industry, you will be responsible for authoring, writing, and reviewing CMC sections of dossiers. Your critical review skills will be essential in examining design stage documents such as specifications, controls, and protocols to ensure compliance with regulatory requirements. You will play a key role in assessing change controls to determine their regulatory impact and develop strategies for post-approval submissions. Coordinating the collection of post-execution data from different functions and reviewing them against design specifications will be part of your daily tasks. Collaboration with cross-functional team members will be crucial for the timely resolution of action items identified to address deficiencies. Your attention to detail will be required to review the accuracy of information in various status reports and databases maintained at the department or organization level. Ensuring regulatory submissions comply with current regulations and guidance will be a top priority. Whether contributing individually or managing a team, you will be instrumental in achieving timely target submissions. Additionally, you will be involved in training and developing individuals to help them reach department and organizational objectives.,

Posted 1 week ago

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