Executive/Senior Executive/Manager - Regulatory Affairs - Pharma

We have opportunity for Executive/Sr Executive/Manager -Regulatory Affairs in Chennai.

Please find the JD below for your reference.

Exp - 3 to 10 years

Work Location: Chennai

Interview Location: Ahmedabad

- Responsible for the review and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections for ANDA/ANDS submissions and ensures effective data presentation as per guidance.

- Responsible for effective coordination with the cross functional teams, site and Global RA teams for authoring, review and finalization of dossiers for the pipeline products to ensure effective data presentation and quality.

- Prepare quality dossiers for pipeline molecules and supplements to support product launch.

- Collaborate with companys- global and other regional regulatory team to author quality regulatory submissions for the pipeline products.

- Reviews health authority queries and co-ordinate global strategy for response.

- Provides adequate support (respond to deficiency letters) to companys- global and other regional regulatory team for securing timely approval of regulatory submissions.

- Provide regulatory support to CFT, participate and provide regulatory advice in technical review.

- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.

- Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, Team lead and core team.

- Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.

- Responsible for ensuring compliance to Company's submission standards, policies and procedures.

Candidates with Injectables background only preferred.

If above job role and requirement matches your profile then apply or call at 044-26512967